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תוצאות חיפוש - Omrix Biopharmaceuticals

נמצא 7 תוצאות בקטגוריה "all"
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משרה
ascdescחברה
ascdescמיקום
בחירה
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 : נס ציונה
בחירה
Quality Systems Manager

Description

Omrix Biopharmaceuticals is seeking a Quality Systems Manager for all sites.
Reports to: Quality Director
Location: the position is in the Omrix Nes-Tziona site.

JOB SUMMARY
Manages the day-to-day operations of the Quality Systems staff. Oversees the development and implementation of processes, procedures, audits and corrective actions. Ensures effective communication and training are deployed throughout the business.
Responsible for providing direction regarding the development and design of quality systems including processes, documentation and computer records.


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

•Ensures compliance of the Omrix Quality Management System with all applicable external cGMP regulations and internal GMP requirements
•Leverages knowledge from MD Quality Systems and J&J Quality & Compliance groups to implement J&J proven quality tools and programs in Omrix.
•Operates as a key business partner for quality and process improvement, understands business requirements and executes quality programs to drive organization capability building.
•Participates in Quality System initiatives to develop and deploy standardized systems across Omrix that meet company needs and advance capability.
•Ensures conformance with all applicable cGMP regulations within the department.
•Develops and drive improvement in the Quality System supporting the Omrix organization specifically, Management Review, Escalation, Trending, Quality Planning.
•Responsible for timely managing and effective closure of any assigned Deviations, CAPA’s and Change Control plans within the department.
•Reviews and approves NCs (non-conformances) and CAPAs (corrective and preventive actions), and SOPs as applicable
•Oversees change control management process for all Omrix sites.
•Oversees document control management process for all Omrix sites
•Oversees record retention management process for all Omrix sites
•Oversees document periodic review management process for all Omrix sites
•Overseas the alignment and implementation of external regulatory and internal J&J standards to Omrix procedures
•Facilitates and execute management review meetings
•Responsible for ensuring adequate training within the department.
•Manages, leads and develops resources within the department.
•Involvement in Environmental, Health and Safety (EHS) aspects as required.
•Responsible for communicating business related issues or opportunities to next management level
•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
•Leads the Device, Labeling and Quality System Departments
•Responsible for all tasks and quality issues related to Devices: Production, Supply chain, QC and final release.
•Supervises the work of team members regarding Medical Device design control activities, complaints investigation, external interfaces with the device manufacturer and sterilization site.
•Oversees Annual Review of devices and its accessories, Device Master Records, Technical Files, 510(k)’s, process validation protocols and reports
•Oversees management of processes for Packaging and Labeling materials for all Omrix sites.

Requirements

8-10 years of related experience and a University/Bachelor’s Degree is preferred.
Experience in the Medical Device industry or medical field
Demonstrated knowledge of manufacturing principles and practices, and procedures
Knowledge of quality systems business practices and software
Ability to work cooperatively with coworkers and
Ability to perform duties in accordance with policies and procedures and in to comply civil rights requirements
Excellent verbal and written communication skills,
Project management skills,
Process excellence tools/methodologies,
Presentation skills,
People leadership,
Talent development.
Preferred System analysis skills,
Engineering background

RESPONSIBILITY FOR OTHERS & INTERNAL INTERACTIONS
•Responsible for managing the following functions:
QA Analyst for labeling
QA systems analyst
Quality systems supervisor
Device Quality Engineer

•Facilitate and participate inn Management Review
•Manages the Quality Manual as well as the GMP guidelines update process and implement all standards that are cascaded down from enterprise level to ensure the compliance of Omrix with changing internal and external requirements.
•Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
•Manages the Site Management Review process and meeting and report the relevant KPIs.
•Deputy of person responsible regulatory compliance for medical device

TRAVEL REQUIREMENTS
•15% expected travel time for domestic & international projects.

EXTERNAL INTERACTIONS
•Supervise on-going follow-up & verification with external manufacturers activities in Israel and abroad.
•Supervise attendance in supplier review boards for external manufacturers and suppliers relating to Device and Labeling.
•Host regulatory audits and notified bodies audits and certification process.

Location: נס ציונה

מיקום : תל השומר
בחירה
Senior Supply Chain Planner - External Operations

Description

Omrix Biopharmaceuticals is seeking a Senior Supply Chain Planner - External Operations.
Reports to the External Operations Planning Manager
Job Summary
•Leads S&OP meetings with external suppliers
•Plans and controls inventory of finished goods to meet sales and distribution demand.
•Analyzes inventory levels, inventory positioning and production and sale forecasts.
•Implements strategies to improve customer service and operational metrics
•Develops planning scenarios and present to management

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:

•Oversees the planning and execution management of complex Medical Device supply chains supported by various external partners
•Monitors and tracks supplier KPIs and develops cross functional mitigation's to address supplier performance issues
•Responsible for developing and monitoring annual supplier purchase plans related to JNJ Business Planning processes
•Partner with Global Planning team to translate country demand forecasts into SKU level purchase plans while meeting inventory targets and minimizing SLOB risk
•Lead Global Supply Chain improvement projects to optimize the External Operations Planning team
•Maintains relationships with key suppliers.
•Develops and implements inventory policies, standards, guidelines, and procedures.
•Plans purchases and inventory per sales forecast, to meet both customer service and inventory targets
•Coordinates and schedules the shipment of finished goods to fulfill contractual agreements with suppliers.
•Reports the supply shortages and surpluses of company products to management.
•Places Purchase Orders for finished goods and raw materials based on sales and inventory targets
•Develops planning scenarios and presents to management
•Acts as planning representative in global projects impacting their supply chains
•Executes ad-hoc planning reports

•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

•Bachelor’s degree in Business, Engineering, Logistics, or Supply Chain related field is required, a Master's degree is strongly preferred
•2-4 years of related experience in Supply Chain / Operations is strongly preferred.
•Technical skills & competencies:
Experience with JD Edwards or similar MRP planning systems is preferred.
Strong analytical skills and advanced knowledge of Excel is required.

•Business skills & competencies:
Excellent organization, time management and interpersonal skills.
Highly detail oriented with exceptional follow-up.
Ability to identify and manage business priorities.
Ability to resolve issues: both technical and supply based.

•Other preferred qualifications:
Experience in the Medical Device industry or medical/pharmaceutical field.
Demonstrated knowledge of manufacturing principles and practices, and procedures.
Demonstrated experience in working with external partners.
Working in a global, matrixed environment.
•Must have flexible working hours to accommodate various time zones
•Must be fluent in English

•Primary location is Omrix, IL but can be based at any Ethicon site
•Estimated 5-10% domestic and international travel

Location: תל השומר

מיקום : נס ציונה
בחירה
Sr. Regulatory Affairs specialist

Description

Omrix Biopharmaceuticals is seeking a Sr. Regulatory Affairs specialist for our Ness Ziona site.
Reports to: RA Manager
JOB SUMMARY
Coordinates, compiles, and submits new product applications, investigation 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 investigation 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.
•Researches 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 deliverable 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 in order 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

LOCATION & TRAVEL REQUIREMENTS
•Location: Ness Ziona
•Occasionally Tel-Hashomer meetings and Business Travels

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

Location: נס ציונה

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***