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תוצאות חיפוש - Omrix Biopharmaceuticals

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בחרו את המשרות שאליהן תרצו לגשת על ידי סימון תיבה אחת או יותר בעמודה השמאלית
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משרה
ascdescחברה
ascdescמיקום
בחירה
מיקום : נס ציונה
בחירה
קניין/ת GROW

תאור המשרה

לאומריקס ביופארמצבטיקה בע"מ דרוש/ה קניין/ת רכש למשרה זמנית ב- GROW לכ- 9 חודשים.
המשרה מיועדת לניוד פנימי בלבד!
הזדמנות להיכנס לעולם שרשרת האספקה, ללמוד ולהכיר את אופן העבודה.
עבודה דינמית בצוות מנוסה, עם הזדמנויות להחשף למגוון ספקים, תחומים וממשקים פנים וחוץ וארגוניים.
תיאור תפקיד
ניהול ספקים וביצוע רכש בהתאם למדיניות בארגון על מנת לספק לחברה מוצרים/שירותים בהתאם לדרישות באיכות, מחיר וזמן המיטביים.
אחראי על הזמנות רכש ותהליכי עבודה מול ספקים תוך כדי ניהול ממשקים מול גורמים בארגון.
מעקב וניהול הזמנות, איתור ספקים חדשים הורדת עלויות, אספקות, הובלת פרוייקטים. סגירת הסכמים מול ספקים, ניהול משא ומתן.

דרישות וכישורים

תואר ראשון
אנגלית- רמה גבוהה - חובה
אופיס - רמה גבוהה חובה לרבות Excel
נסיון בעבודה עם מערכת ERP
ניהול מו"מ - יתרון
יכולות תקשורת ושיתוף פעולה גבוהות
יכולת לעבוד תחת לחץ בסביבה דינאמית

מיקום: נס ציונה

הערות

המשרה מיועדת לניוד פנימי בלבד!
משרה זמנית ב- GROW לכ- 9 חודשים.
מיקום : נס ציונה
בחירה
HR Business Partner and OD Lead

Description

Omrix Biopharmaceuticals is seeking for a HR Business Partner and OD Lead.
We're part of Johnson & Johnson company.
It is a great opportunity to join a leading global company who develops and manufactures lifesaving products.
The employment through an outsourcing company for 9 months

•Provides complex consulting services to business partner client groups.
•Promotes excellent employee relations through accurate interpretation and administration of HR policies and programs.
•Provide HR support, thought partnership, and coaching to all levels of the organization
•Assists in the facilitation and implementation of HR plans and programs related to organizational design, development, leadership coaching, and team building that support change and growth
•Proactively assess team and manager development needs, make recommendations, and implement appropriate solutions
•Provides ad hoc reporting on program effectiveness, turnover, and other measurements.
•Provide rigorous data analysis and reporting solutions based on business needs
•Execute on global talent management strategies to support a team’s growth and individual development plans
•Initiates the design, development, implementation and administration process and activities of organization development and training programs.
•Manage and facilitate the overall Performance Summary Cycle and employee engagement survey throughout the year
•Integrate and partner with HR colleagues in the Recruiting, Learning & Development, Compensation, Legal, and HR Programs to implement solutions to support the business strategy and goals
•Supports HR Projects planning and implementation.
•Work closely with our people leaders and ER/LR partner, supporting employee relations issues as needed
•Participate as an integral member of the extended HR community
•Consults with management, employees, and departments to identify development needs to achieve the end result of an effective development and training solutions.
•Provides expertise and operational support in the identification, development and implementation of best practices and process improvement for organizational development.
•Coordinates and tracks org. development processes, programs, tools, resources and resolve issues.
•Revises, maintains organization development intervention resources, processes, and tools.
•Initiate edit and coordinates training for employees and leaders regarding human resources issues.
•Use analytics tools to derive insights to inform talent and HR strategies in support of local, sector, regional and/or enterprise business goals and evaluate org. development and training effectiveness
•Responsible in developing and tracking budget.

Requirements

•At least 6+ years' experience as HR Business Partner or equivalent role
•Demonstrates solid judgment and experience assessing risk relative to the business
•Demonstrates project management and change management experience
•Effective communication and problem-solving skills
•Demonstrates empathy and experience driving inclusion work
•Experience learning and thriving in a constantly changing environment and to cultivate relationships across teams
•Experience using data to identify insights that drive action
•Experience helping global and/or matrixed organizations scale
•BA/BS or above degrees in HR or related filled

Location: נס ציונה

Comments

The employment through an outsourcing company for 9 months
מיקום : תל השומר
בחירה
Production Team Leader

Description

Omrix Biopharmaceuticals is seeking a Production Team Leader, for our SD and Gamma lines in Tel-HaShomer site.
This position is open for INTERNAL MOVE ONLY
Reports to Production line Supervisor

JOB SUMMARY
Responsible for managing production personnel to maximize quality and output in a manufacturing operation. Accountable for achieving production targets while maintaining cost controls.

DUTIES & RESPONSIBILITIES
Under limited supervision and/or general directions and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
Supervises production operation and work to meet production goals. Establishes personnel schedules and product lines based on business needs. Provides input to production flow and identifies potential manufacturing issues. Tracks production orders and schedules. Compiles and submits data for production and operating reports. Trains staff in the areas of safety and quality. Reviews work to ensure compliance with the standards. Schedules or performs training for all employees. Recommends changes to standard operational and working practices. Educates employees and observes to ensure understanding and compliance. Provides input to operational budget. Manages costs to improve business' financial results. Administers equipment maintenance and repair. Maintains records and notifies management of reoccurring issues that may require equipment replacement.
Responsible for communicating business related issues or opportunities to next management level. In case supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable. Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures, performs other duties assigned as needed.

Requirements

High School Diploma
1-2 years of related experience or equivalent-is preferred.
Previous experience in a pharmaceutical manufacturing environment-is preferred.
Knowledge of and compliance with CGMP (Current Good Manufacturing Practices) regulations, preferred but not required.
Basic Computer skills.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS.
•Able to read and understand English procedures and instructions.
•Demonstrate knowledge of manufacturing principles and practices.
•Ability of meeting tight schedules and achieving tasks due dates according to plan.
•Ability to perform review of batch records and data spread sheets in high accuracy and ensure compliance with protocols and standards.
•Verbal and written communication skills.
•Organizational and leadership abilities.
•Presentation, guidance and training skills.
•Problem-solving skills
•Ability to work cooperatively with coworkers and other departments and interface.
•Ability to motivate employee under his/her responsibility and Promotes positive employee relation.
•Ability to maintain and motivate operators for 100% compliance maintenance in all SOP, cGMP, EHS and other training curriculum as assigned.
•committed to implement high standards of health, Environment and safety
•Ability to perform duties in accordance with policies and procedures, follow cGMP and comply with Industry and regulations requirements
•All other duties may be assigned as required.

ADDITIONAL POSITION REQUIREMENTS
•The job schedule requires work in 3 shifts, weekend and overtime as needed.
•Operate and monitor operation of specialized pieces of equipment.
•Required for checking and verification of all operations and activities performed by department operators and junior staff during a shift.
•Informing line Supervisor of any nonconformance', safety or quality events which occurred or reported during the shift.
•Opens new department nonconformance's in the company quality system as require, Participates in investigations when applicable.
•Reporting to Department manager supervisor.
•Direct managing various employees including shift coordinators and operators.

RESPONSIBILITY FOR OTHERS & INTERNAL INTERACTIONS
•This position will directly report to main line Supervisor of the relevant department.
•Works with other departments and functions as relevant.

PHYSICAL WORKING CONDITIONS / REQUIREMENTS
•This position will be partially performed in a clean room production environment which requires certain preparation and gowning practices
•Ability to work in a special environment such as a clean room
•Ability to wear protective garb such as clean room gowns
•Must be able to stand for long periods of time
•Must be able to move short distances quickly and frequently
•Must be able to perform lifting, pulling and pushing movements.
•Must be able to complete repetitive movements for extensive periods of time


Location: תל השומר

Comments

This position is open for INTERNAL MOVE ONLY
* The opportunity is for production employees
מיקום : נס ציונה
בחירה
Senior Regulatory Affairs specialist

Description

Omrix Biopharmaceuticals is seeking a Sr. Regulatory Affairs specialist.
location Nes Ziona, Israel
Reports to: RA Manager

JOB SUMMARY:
Plans, coordinates, compiles, and submits new product applications, investigational new product applications and post approval supplements to regulatory agencies in multiple regions. Assembles information necessary for submissions in accordance with regulations and relevant guidelines. Ensures compliance with regulatory agency regulations and current thinking. Prepares responses to regulatory agencies' questions and other correspondences.
Leads regulatory specialists and reviews early stage regulatory strategies and submission packages. Involved with the preparation of necessary outlines, summaries and status reports. Provides solutions to a variety of problems of moderate scope and complexity. Organizes and maintains reporting schedules for new product application and investigational new product applications.

DUTIES & RESPONSIBILITIES:
•Review and provide regulatory assessment for changes in approved product, in coordination with regulatory affiliates in global regions
•Prepare and submit required regulatory applications for new products and maintenance of existing products with limited supervision
•Prepare and maintain an annual and periodic plan of activities
•Support other RA specialists: provide guidance to junior members, track team’s assignments, reviews regulatory strategies and submissions
•Interacts with regulatory agency personnel in order to expedite approval of pending applications and to resolve regulatory matters with limited supervision
•Communicates information and presents status updates on product/project activities to key internal/external stakeholders when requested
•Follows up of mandatory requirements for registration: local certificates, importation of samples and local testing, etc. with limited supervision
•Monitors and submit regulatory applications for changes of approved products with limited supervision
•Researches and consolidate regulatory requirements and communicate the information to RA and project managers
•Supports in the development of best practices for Regulatory Affairs processes
•Supports the RA team in projects, ensure record keeping and filing and submit reports and deliverables timely
•Partner effectively with key business partners to assure strategic objectives for Omrix are achieved
•Provides training and limited supervision to regulatory specialists

Requirements

•Minimum of a B.Sc. in engineering, biological, pharmaceutical, or chemical sciences
•Minimum of 3 years of progressive experience in Regulatory Affairs

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS:
•Leverages working knowledge of the regulatory environment to prepare compliant regulatory strategies, provide regulatory input to product life-cycle management and evaluate regulatory impact on products
•Track requirements of regulatory agencies and implement file updates accordingly
•Lead regulatory projects in cooperation with cross organization functions
•Write and coordinate submissions and responses to health authorities in global market
•Effectively manages multiple competing priorities and collaborates with project teams
•Manages large amount of complex information and make timely and effective decisions for the execution of project objectives
•Acts with speed, agility and accountability in the decision making and balances short and long-term decisions and activities. Demonstrates an enterprise-wide mindset.
•High level English

RESPONSIBILITY FOR OTHERS & INTERNAL INTERACTIONS:
•Ongoing collaboration with other departments such as QA, QC, R&D, MSO
•Participate in the weekly RA and project team meetings

EXTERNAL INTERACTIONS:
•Regular contact with Ministry of Health, FDA, EMA, Health Canada, ROW affiliates

Location: נס ציונה

מיקום : נס ציונה
בחירה
Regulatory Affairs Manager

Description

Omrix Biopharmaceuticals is seeking a Regulatory Affairs Manager.
Primary location Nes Ziona, Israel. Remote work opportunity available in Europe or any reasonable time zone will be considered.
Reports to: Senior RA Manager

JOB SUMMARY
Leads, train and develop a team of regulatory affairs professionals according to the requirements and responsibilities of the position, including end-to-end management of life-cycle changes, from regulatory evaluation, through regulatory project management, plan regulatory strategies, design and review of qualification studies, results and scientific justifications, and up to compilation of submission packages and responses to information requests. Schedules and manages periodic submissions to verify compliance with regulatory requirements. Prioritizes tasks according to department workload and capabilities. Provides solutions to a variety of problems of moderate scope and complexity, and status reports to senior management.

DUTIES & RESPONSIBILITIES
•Accountable for all regulatory assignments of the RA team, including:
Performing and documenting regulatory assessments of life-cycle changes according to regulatory requirements of the U.S. FDA, E.U., and rest of world (ROW)
Developing a robust submission strategy according to regulatory requirements in all regions, including required studies and study design
Reviewing of all study reports, scientific justifications and additional submission documentation
Identifying and communicating regulatory risks and mitigations
Compiling submission package
Responding to information requests from global Health Authorities

•Exploring submission pathways and regulatory opportunities, and recommending the most appropriate route according to regulation and business needs and priorities
•Utilizes strategic regulatory thinking along with technical expertise to implement regulatory strategies for post approval changes
•Provides regulatory guidance to project team members regarding health authority requirements for validation and submission
•Performs final review of regulatory assessments, regulatory strategy, study design, risk register and submission package
•Organizes and maintains reporting schedules for new product application, investigational new product applications, post approval projects and periodic submissions
•Manages team resources and prioritizes projects and tasks according to workload, business needs and capabilities
•Coordinates all activities concerned with the strategy, submission, and approval of products to government regulatory agencies between internal and external functions
•Establishes accountability for the preparation of necessary outlines, summaries and status reports for senior management and project stakeholders
•Ensures adherence to standard operating procedures and protocol for the rapid and timely approval of new drugs and regulatory support of marketed drugs and other products
•Interacts with regulatory agency personnel in order to expedite approval of pending application and to resolve regulatory matters
•Develop CMC regulatory strategies which meets global regulatory requirements over the lifecycle of the product
•Coordinate project submission timelines in multiple regions
•Provides regulatory expertise and recommendations to facilitate successful product development globally
•Escalates issues to CMC Regulatory Affairs Senior Management that affect registration, regulatory compliance and continued lifecycle management of the product
•Responsible for talent development of team members
•Identifies and implements improvements to regulatory processes and procedures

Requirements

•Minimum of a B.A. or B.Sc. or undergraduate degree is required.
•Undergraduate degree in engineering, biological, pharmaceutical, or chemical sciences and/or an advanced degree (i.e. Phar.D. or Ph.D.) is preferred.
•Minimum of 8 years relevant/regulated industry experience is required.
•Minimum of 5 years of relevant progressive experience in CMC / technical regulatory affairs is required
•3+ years of direct People leadership and Management experience is preferred

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS.
•Demonstrated ability to communicate regulatory requirements clearly, accurately, and concisely
•Strong knowledge of global health authority laws, regulations, guidance and the regulation submission route available for assigned products
•Experience developing regulatory strategies and an understanding of the product development process
•Expertise in product development and its application in global regulatory strategy
•Solid understanding of biology, chemistry and/or engineering relevant to pharmaceutical and/or biologic industry
•Experience leading/managing regulatory affairs professionals
•High-level verbal and written communication skills, fluent in English

RESPONSIBILITY FOR OTHERS & INTERNAL INTERACTIONS
•Management and leadership of Regulatory Professionals
•Ongoing collaboration with other departments such as QA, QC, R&D, MSO
•Communicating to Regulatory leadership and Business Operating Committees
•Project core team member

LOCATION & TRAVEL REQUIREMENTS
•Primary location Nes Ziona, Israel. Remote work opportunity available in Europe or any reasonable time zone will be considered.
•Occasionally internal meetings in Ramat Gan and international Business Travel (Europe, U.S.) (0%-10%)

EXTERNAL INTERACTIONS
•Regular contact with Israeli Ministry of Health, FDA, EMA, Health Canada, Rest of World (ROW) agencies if needed.

Location: נס ציונה

Comments

Primary location Nes Ziona, Israel. Remote work opportunity available in Europe or any reasonable time zone will be considered.
מיקום : נס ציונה
בחירה
Supplier Quality Lead (GROW)- for internal move ONLY

Description

Omrix, a Biopharmaceutical company, is seeking a Supplier Quality Lead (GROW).
GROW position until the end of 6/2021

This position will be responsible for the approval planning, execution, and documentation of the qualification and monitoring for suppliers and/or external manufacturers who input into the Ethicon Biosurgery Supply Chain for the manufacture of blood product Intermediates, APIs, or drug products.
Providing Quality and Compliance oversight by ensuring quality standards are achieved and maintained at our Suppliers and External Manufacturers to meet J&J requirements and for inclusion on MD Global Biologics Approved Supplier List
This oversight includes ensuring continuous compliance with relevant regulatory health authority requirements, effective risk management, strategy development and execution, and effective collaboration between R&D, Operations, Procurement, TechOps, Regulatory Affairs and other technical disciplines (EHS). Functions and activities include quality assurance review and approval functions (such as Change Control, Deviation Handling), compliance audit activities, creation and management of risk mitigation plans for suppliers and external manufacturers.
This position requires the ability of building collaboration and teamwork across the local and global Ethicon Biosurgery organization, and it interfaces Ethicon Biosurgery Supplier Quality with the quality unit of suppliers and external manufacturers.
This position reporting to Supplier Quality Manager ETH Biosurgery.
ESSENTIAL FUNCTIONS
Oversees compliance of existing supplier base and executes upon Supplier Quality Systems requirements assuring adequate controls over sourced goods and services. Effects and permanently maintains inspection readiness at third-party manufacturers and material-suppliers. Supporting of third-party manufacturers and suppliers during regulatory inspections and audits and during the development of corrective action plans.
Surveillance on the quality and compliance status for all suppliers and/or external manufacturers of raw materials, packaging materials, intermediates, excipients, APIs and service providers.
Performing audits at suppliers and external manufacturers
Management of Change related to supplier and/or external manufacturers
Assessment of deviations, corrective and preventative actions, and complaints concerning suppliers and external manufacturers
Provision of all information needed for the release/reject of suppliers.
Establishment and periodic review of Quality Agreements
Initial assessment and qualification of suppliers and external manufacturers for new product introductions, and establishment of initial Qualification Statements
Periodic performance measurement for suppliers and external manufacturers
Help in preparing external manufacturers for and support during health authority inspections
Supplier Quality representative and subject matter expert (SME) during regulatory audits at Ethicon Biosurgery sites

Requirements

A minimum of 5 years' working experience with 2 years' experience in MD/biological industry, commercial manufacturing and/or R&D environment;
Experience in Quality Assurance, Quality Control and/or Compliance; previous experience in a Supplier Quality role is strongly preferred.
Having the ability to provide cGMP compliance support to contract manufacturers by investigating and resolving quality issues;
Excellent interpersonal, written, oral and presentation skills (English).

Location: נס ציונה

Comments

*FOR INTERNAL MOVE ONLY*
מיקום : נס ציונה
בחירה
QA Manager, FPPF- for internal move ONLY

Description

Omrix Biopharmaceuticals is seeking a QA Manager, FPPF for internal move ONLY.
Reports to: Quality Director
Location: the position is in the Omrix Nes-Tziona site.

•Establishes and maintains quality assurance programs, procedures, and controls. Ensures that performance and quality of products conform to established company and regulatory standards.
•Reporting to quality director and a member of the quality management team.
•Responsibilities over quality issues at all departments (including but not limited to Production, packaging, supply chain, QC Laboratory).
•Responsibilities over all QA release activities.
•Member of the site leadership team.




Requirements

•BSC. degree, Life Science, Physical Science, Engineering or other related field required.
•Minimum of 4 years of experience in compliance or quality in a regulated (FDA) environment.
•Experience in people management – preferred
•Experience in biopharmaceutical manufacturing is required, experience with combination products is preferred.
•Experience in handling patient/customer complaints, inquiries or servicing issues preferred
•Experience interacting with FDA, EMA and other regulatory agencies preferred

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS.
•Experience or proven record motivating leading and developing staff, in a highly changing environment.
•Demonstrating fortitude to make Quality calls.
•Working through multiple set-backs and unforeseen challenges.
•Six Sigma, Quality Engineer or Quality Auditor Certifications are preferred.

Location: נס ציונה

Comments

For internal move ONLY.
מיקום : תל השומר
בחירה
עובד/ת למעבדת בקרת איכות

תאור המשרה

לחברת אומריקס ביו-פרמצבטיקה לאתר החברה בתל השומר דרוש/ה עובד/ת למעבדת בקרת איכות (QC)
תפקיד מגוון ומאתגר בצוות הכולל:
עבודה בסביבת GMP
ביצוע בדיקות ביוכימיות מגוונות
מעורבות אישית בפרויקטים שונים במעבדה כגון שיפור שיטות, כתיבת פרוטוקולים, חקירות של חריגים. הכתיבה היא באנגלית בלבד.
התפקיד מהווה הזדמנות מצוינת להשתלב בתעשיית התרופות.

דרישות וכישורים

תואר ראשון/שני מתחום מדעי החיים (המשרה לא מתאימה ל PHD )
ניסיון של לפחות שנה בתנאי GMP מהתעשייה הפרמצבטית - חובה
נכונות לעבודה במשמרות - חובה
נכונות לעבודה בימי שישי (1-2 פעמים בחודש)
נכונות לעבודה בשעות נוספות לפי הצורך-חובה
אנגלית ברמה גבוהה כולל כתיבה-חובה
ידע באופיס ברמה טובה-חובה

מיקום: תל השומר

הערות

***אנו מגייסים למשרה זו לעיתים קרובות. כרגע אין גיוס פעיל, אך נשמח לקבל קורות חייך ולהיות בקשר לכשתפתח המשרה מחדש***
מיקום : תל השומר
בחירה
Quality Engineer

Description

Omrix Biopharmaceuticals is seeking a Quality Engineer, for our Tel-HaShomer site.
Reports to QA Lead.

Perform evaluation of Non-Conformance
Lead RRT and Non-Conformance meetings
Manage ICQA's
Review completeness of documents such as: procedures, forms, protocols and validations
support projects as required
Support quality systems issues (CAPA's, Non-Conformance and changes)
Perform risk evaluation and product impact assessment
Support audits preparation (internal & external)
GMP/ Compliance Improvements
Ensure compliance with Omrix and JNJ quality systems requirements

Requirements

B.Sc./M.Sc. in science
Minimum of 4 years' experience in GMP
Experience in Quality Assurance
Great interpersonal relationship
Organized and meticulous
Independence and prioritizing abilities
High technical-oriented skills and technical writing ability

Location: תל השומר

Comments

***אנו מגייסים למשרה זו לעיתים קרובות. כרגע אין גיוס פעיל, אך נשמח לקבל קורות חייך ולהיות בקשר לכשתפתח המשרה מחדש***
מיקום : תל השומר
בחירה
עובד/ת ייצור

תאור המשרה

לחברת אומריקס ביו-פרמצבטיקה דרוש/ה עובד/ת ייצור לעבודה בתל השומר.
העבודה במשמרות וכוללת לילות וסופ"ש .
תיאור המשרה:
עבודת צוות בחדרים נקיים.
ניקיון הרצפה, המכונות והחדר.
פירוק, ניקיון והרכבה של מכשירי ייצור.
עבודה לפי נהלים ותיעוד התהליך.

העבודה בשלוש משמרות :
7:00-16:00 / 14:00-23:00 / 22:00-07:00

דרישות וכישורים

הנדסאי/ת- יתרון.
ניסיון קודם מהתעשייה הפרמצבטית/מזון/קוסמטיקה וכד' - יתרון משמעתי
ידע בנהלי GMP- יתרון.
ידע בפריוריטי - יתרון.
אנגלית קריאה והבנה- חובה.
עברית - הבנה - חובה
רוסית- יתרון

מיקום: תל השומר

הערות

***אנו מגייסים למשרה זו לעיתים קרובות. כרגע אין גיוס פעיל, אך נשמח לקבל קורות חייך ולהיות בקשר לכשתפתח המשרה מחדש***