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תוצאות חיפוש - Omrix Biopharmaceuticals

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משרה
ascdescחברה
ascdescמיקום
בחירה
מיקום : נס ציונה
בחירה
Assistant Controller

Description

Omrix Biopharmaceuticals, a Johnson & Johnson subsidiary, is looking for a vital, dynamic, enthusiastic and reliable Assistant Controller to assist in preparing statements that follow all regulatory and accounting guidelines under the supervision of a Finance Manager.
An effective assistant controller has good knowledge of accounting principles. You must be organized professionals with a great eye for detail. You must be reliable and able to carry out tasks autonomously and collaboratively.
Responsibilities
• Assist in the preparation of financial statements, corporate reporting package, in compliance with US GAAP
• Participate in preparation for the annual and tax audits
• Assist in the formulation of internal controls and policies to comply with legislation and established best practices
• Intercompany reconciliations
• Help in development of reports for management and regulatory bodies
• Review the company’s accounting information to identify and resolve inaccuracies or imbalances
• Participation in cross organizational projects
• Utilize accounting IT system to facilitate processes and maintain records

Requirements

• Manager/ Senior at a Big 4 firm- a must
• Professional certification (CPA)- a must
• BSc/BA/MBA` in accounting, finance or relevant field
• Solid knowledge of US GAAP and local taxation- a must
• Understanding of data analysis and forecasting
• Ability to work under pressure in a multi-tasking environment.
• Working knowledge of MS Office (especially Excel and PowerPoint) and accounting software
• Well-organized with ability to prioritize
• Very good communication and interpersonal skills
• Attention to detail and problem-solving ability

Location: נס ציונה

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

מיקום : נס ציונה
בחירה
Sr. Regulatory Affairs specialist

Description

Omrix Biopharmaceuticals is seeking a Sr. Regulatory Affairs specialist.
location Nes Ziona, Israel
Reports to: RA Manager
JOB SUMMARY
Coordinates, compiles, and submits new product applications, investigational new product applications and post approval supplements to the regulatory agencies. Ensures compliance with regulatory agency regulations and interpretations. Prepares responses to regulatory agencies' questions and other correspondence. Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines. Involved with the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides. 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 WW regulatory assessment for changes in approved product (CCs, Supplier notifications, New projects)
•Prepares and submit required regulatory applications for new products and maintenance of existing products with limited supervision.
•Prepare and maintain an annual and periodic plans of activities
•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.
•Research and consolidate regulatory requirements and communicate their information with supervisor and manager.
•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.
•Act as an Omrix representative to projects handled as needed in the area of medical device, biologic and combination product registration
•Maintain professional knowledge
•Provides training and limited supervision of contract resources, as needed.
•Conforms regulatory compliance.



Requirements

•A minimum bachelor's degree – Pharmacy, Biology, Biochemistry, Chemistry
•Min. 3 years of progressive experience in Regulatory Affairs
REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS.
•Leverages a working knowledge of the regulatory environment to prepare compliant Regulatory strategies and scientific and technical understanding of medical devices to provide regulatory input to product life-cycle management and evaluate regulatory impact on products.
•In depth understanding of Omrix manufacturing processes, analytical testing and
•Provide Regulatory Affairs support: Generates and manage submission documents for new products or changes to existing files.
•Must be able to proactively develop partnerships and alliances across the business.
Engages with external stakeholders and demonstrates conviction, proactivity and persistence when influencing others and overcoming resistance. Creates compelling negotiating positions that builds support and consensus among key stakeholders. And builds and leverages internal and external networks with colleagues, cross-functional partners, and industry contacts to identify opportunities and open communication channels.
•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 stakeholders with differing needs and viewpoints to make the best possible decision. And consistently manages large amount of changing, complex, ambiguous information and makes timely and effective decisions for the execution of project objectives.
•Delivers and creates oral and written technical communication with highlighting the most pertinent information for targeted stakeholders and leads to desired stakeholder actions.
•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
•Work with another department such as QA, QC, R&D, MSO
•Participate in the weekly RA team meetings

Location: נס ציונה

מיקום : נס ציונה
בחירה
Sr Strategic partnership & Operation Manager

Description

Omrix Biopharmaceuticals, a Johnson & Johnson company, specializes in the development and manufacturing of life-saving products based on human plasma.
At Omrix, you’ll be part of a company with a global vision and values, where excellence, professional partnerships and self-fulfillment all serve our mission to save lives.
We are seeking a Sr Strategic partnership & Operation Manager, Primary location Ness Ziyona, Israel.
Direct report to Omrix General Manager

We are looking for an ambitious and energetic Sr Strategic partnership & Operation Manager who will help us leading Omrix external relationships and future business engagement.
You will serve as the company front line shaping and implementing our business strategy.
Our goal will be to drive sustainable operation and financial sustainability and growth by strengthening relationships and ensure close coordination and collaboration with the business internal and external partners both locally and globally.
You will be asked to assess business operational model to optimize and increase efficiency and enable flexible operation to accommodate new production mix.
In order to accomplish your role, you will be working in partnership with global corporate functions such as Business Development, Legal, Finance, Strategy & Deployment, etc.

DUTIES & RESPONSIBILITIES:
•Seeking for business opportunities for business efficiencies opportunities.
•Lead negotiation with key strategic partners; work closely with legal experts to write contracts for continuance business support.
•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 country and Company regulations, policies, and procedures
•Identify operational models for profitability
•Following industry trends locally and internationally
•Performs other duties assigned as needed

Requirements

•6 + years of experience in Business Development and proposal of Strategic development, global experience is necessary
•Education: Bachelor’s degree in Business Management/ Economics / Marketing / Legal- mandatory; MBA – an advantage
•Experience with design and implementation of business development strategy proof experience – preferred
•Prior experience of managing multifunctional projects at global companies
•Experience with negotiating and contracting capabilities a must
•English language fluency required
•Demonstrated leadership and organizational skills with excellent personal relationship capabilities
•Experience in working in complex matrix work environment
•Legal background and / or experience – an advantage

Location: נס ציונה

מיקום : נס ציונה
בחירה
Senior Manager, Pharmacovigilance

Description

Omrix Biopharmaceuticals is seeking a Senior Manager, Pharmacovigilance
JOB SUMMARY
Worldwide responsibility for the establishment and execution of the Ethicon Biosurgery Quality and Pharmacovigilance System compliant with international regulations for Biologic products and accessories, including, but not limited to:
•Complaint handling, investigations and AE reporting for Omrix, Limerick and Bioseal
•Collaboration with Regulatory Affairs, Medical Affairs, Clinical Development and Quality Assurance to support the identification of issues and the necessary actions to assure continued safety and efficacy of marketed products worldwide.
•Continued enhancement of the Biosurgery Quality System in response to changing regulations, QS performance and improvement opportunities, and business needs, with consideration of the interaction of the Biologic Quality System with the Ethicon Franchise Quality System.

This position will report directly to the Senior Director, Ethicon Quality Systems, and has the responsibility to supervise the Quality Systems and Pharmacovigilance group.

DUTIES & RESPONSIBILITIES
Under limited supervision, and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

•Provides strategic direction to global business partners and senior management on the execution of pharmacovigilance and quality systems related topics. Adjust and monitor strategic direction in response to changing regulatory and business environment.
•Proactively communicate potential safety signals and provide strategic direction for addressing concerns to global business partners and senior management.
•Develop pharmacovigilance and quality system strategies for current and emerging markets
•Lead interactions with global Health Authorities with respect to post-market commitments, safety reporting and field actions related to safety & quality issues
•Represent Pharmacovigilance and Biosurgery Quality Systems during internal and external audits.
•Implement the quality system strategy and standards for the Biosurgery business platform across all Biosurgery locations globally. Identify opportunities to leverage Ethicon Franchise and Enterprise capabilities, including process integration.
•Harmonize, maintain and continuously improve quality systems, including quality manual, Management Review, configuration management, change control, records management and associated technologies and procedures that support the development, manufacture and delivery of high-quality products in order to meet J&J and external regulatory requirements, as well as customer expectations.
•Monitor Quality System and Pharmacovigilance performance measures and provide strategic reaction to negative trends. Utilize data and changing internal and external environment to identify any new performance measures and identify measures that can serve as leading indicators of issues.
•Represent Biosurgery Quality Systems and Pharmacovigilance in the Ethicon Quality System organization and on Enterprise teams and initiatives.
•Participate on Ethicon Franchise Quality Systems and Biosurgery Quality leadership teams.
•Recruitment, training and assessment of direct staff
•Responsible for communicating business related issues or opportunities to next management level
•For those who 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

EXPERIENCE AND EDUCATION*
•MS/MA or higher in a scientific/technical field.
•5+ Years of job-related experience
•3-5 years supervisory experience

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS*
•Ability to work independently
•Ability to communicate (written and verbally) effectively with all levels of management and across multiple functions and geographies
•Management/Supervision of technical and non-technical personnel.
•Understanding of interaction of the comprehensive Quality System across different processes and functions
•Specific understanding of EU GVP, ICH Q8/Q9/Q10, 21CFR 210/211/600, QSR and ISO 13485 requirements
•Good computer skills and basic statistical knowledge
•Experience in pharmaceutical medicine, including drug safety is preferred

LOCATION & TRAVEL REQUIREMENTS
•This position may be based at either the Somerville (NJ) or Cincinnati (OH) site, and will require 25-35% travel, including some international travel.

Location: נס ציונה

מיקום : תל השומר
בחירה
Business excellence Manager

Description

Omrix Biopharmaceuticals is seeking a Business excellence Manager, to lead J&J SC Business Excellence programs across all sites.
Primary location of the position in Omrix Tel-Hashomer site. Serve Nes-Ziona site with frequent visits and routines.
Direct report to Omrix General Manager

JOB SUMMARY
•Researches optimum routing, cost, quality, and morale through service in routine activities and the development, recommendation, and implementation of projects.
•Sponsoring global plans related to lean transformation (JJPS).
•Leading, development and implementation of organizational metrics and reports. And control of cross-organizational processes
•Applies management routines to ensure efficient work and waste reduction.
•Shape Omrix strategy to enhance Omrix value creation and service level.
•Member of Omrix leadership team

DUTIES & RESPONSIBILITIES
•Lead Cost Improvement Program- by facilitating brainstorming sessions, building business cases, bringing to go/no go decision and monitoring actual savings of the company's cost related projects.
•Facilitate routines to monitor status of strategic projects (Projects Portfolio Management) and issues impacting service level.
•Responsible for capabilities building with business excellence trainings- Lean, Six-Sigma, Project Mgmt.
•Key leader in performance management routines to ensure flags are being raised on time and the right KPIs are being monitored
•Interprets labor standards by conducting time studies and evaluating methods used in operational areas and build labor models.
•Applies statistical methods and performs mathematical calculations to determine manufacturing processes, staff requirements, and production standards.
•Implements and communicates changes to methods for improving worker efficiency and reducing waste of materials and utilities such as restructuring job duties, reorganizing workflow, relocating workstations or equipment.
•Responsible for communicating business related issues or opportunities to next management level
•Program management, formulation of new processes, task controls and direct interface to management members, and works with other department to ensure that a variety of business transactions are completed
•Direct managing the Omrix JJPS lead

Requirements

•Industrial Engineer- University/Bachelor's Degree or Equivalent
•+8 years proven experience in Business Excellence roles. advantage to experience from a leading consultancy firm
•+2 years leadership / managerial roles experience
•Experience in the Pharma or Medical Device industry - an advantage
•Demonstrated knowledge of operation principles, practices, and procedures
•Experience using Excel, able to analyze data on spread sheet and database applications
•English language fluency required
•Strong personal skills- Ability to communicate effectively with a diverse clientele base
•Ability to work in a matrix complex environment, build partnership and collaborate with cross functions and coworkers

REQUIRED KNOWLEDGE, SKILLS, ABILITIES
•English Verbal and written communication skills – very high level
•Project management - (FPX, Agile)
•Problem solving
•Six sigma and process excellence tools/methodologies- Black belt / Green belt are an advantage
•Presentation skills
•Training/education methodologies skills
•Ability to lead cross functional (lead without authorities)

Location: תל השומר

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 : 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***