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תוצאות חיפוש - Omrix Biopharmaceuticals

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משרה
ascdescחברה
ascdescמיקום
בחירה
Business Unit Finance/Financial Planing&Analysis Manager

Description

Omrix Biopharmaceuticals is seeking a professional for the position of BUF/FP&A Manager .
Omrix is a Sourcing MRC – responsible for Sourcing activities and reporting (Inventory, ICP's, Costing and STD setting etc.).
Report to the Biosurgery Supply Chain Finance Director and will be based in Israel. The BUF Manager provides financial acumen and is a key business partner and member of the Omrix Plant leadership team while collaborating with several internal, cross-country & external partners.

Responsible for shaping and delivering insight and actions to maximize production value of biological products produced at Omrix, by delivering data analysis & insights while partnering with Plant Leadership to drive efficiencies and value. support the Biosurgery Finance Director in various cross functional projects, including A&D, Value Streams, Transformation etc.


MAIN TASKS:
•Business Unit Finance Partner to the Omrix GM and Plant Leadership
•Lead a finance team of 4 analysts
•Biologics Value Stream Finance Partner – partner and contribute the to the E2E Biologics Value Stream and Strategy, partnering with multiple stakeholders
•Support the Biosurgery Finance Director in various cross functional projects, including A&D Transformation etc.
•Lead the financial planning of the business plan/updates encompassing the preparation, consolidation, and review of the detailed financial analysis
•Lead periodic financial performance reviews with Plant and Biosurgery leadership
•Active participation in BU Meetings & Strategic Plans.
•Actively contribute and influence well-informed decision-making through financial analysis and insights by providing relevant KPI’s
•Set objectives, actions & follow-up to promote a cost control through encouraging the Business Unit to adopt improved processes & performing detailed cost monitoring.
•Automate and optimize processes and build a well-structured reporting package
•Drive accountability and ensure compliance with the J&J WWP as well create and own relevant finance compliance policies and procedures.
•Lead the development of business cases for capital investments including Network Strategy decisions within the platform

Requirements

•University/Bachelors’ Degree or Equivalent in Finance, Accounting or Economics
•At least 6 years of relevant experience
•Proven managerial experience - required
•Business experience in some of the following areas: Finance, Budgeting, Manufacturing, Project Management, Mergers & Acquisitions, Source Finance
•Trusted business partner with strong interpersonal skills, team-player mindset and collaborative working style.
•Strong Strategic Leader with ability to handle complexity and ambiguity in periods of change, under pressure.
•Strong Influencing skills across cultural differences and ensuring management understands the Financial priorities and constraints, ability to align business partners on tough financial calls
•Enterprise mindset, Familiarity with Credo values, Ability to develop talent and organizational culture
•Technical skills: Computer competency (Priority knowledge an advantage), Financial and Accounting Acumen, Excellent Written and Oral Communication skills
•Strong analytical capabilities
•Ability to work with people in a virtual environment
•Committed to high standards of Compliance and Credo compatible behavior.
•Languages: Hebrew and English

Location: נס ציונה

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 : 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
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***