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Bedrijf USG Professionals Science

Sector Farmaceutisch

Type Vaste job

Regime Voltijds

Uren/week 40

Opleiding Master

Talen Nederlands, Engels

Ervaring Minstens 2 jaar ervaring

158 Online sinds

Het bedrijf

USG Professionals, unit science, zet engineers flexibel in. Bedrijven doen snel en eenvoudig beroep op onze specialisten voor korte en lange termijn opdrachten in gespecialiseerde domeinen. Engineers vinden bij USG Professionals afwisseling, aantrekkelijke werkzekerheid en ruime opleidingsmogelijkheden. Klanten doen beroep op ons vanwege onze expertise op engineer vlak. Kijk op onze website voor de laatste engineering jobs, het laatste nieuws en opleidingsmogelijkheden.

Functieomschrijving

General Summary

Establish and maintain a robust compliance program to ensure compliance with local, national and international regulatory standards, company policies and procedures, and company corporate requirements. Coordinate and deploy sector policies and standards, as well as maintain specific onsite quality systems, as required. Partnering with European manufacturing plants and key business partners:

 

• Maintain quality systems, including but not limited to: document management, training program, external audits and internal auditing program.
• Monitor and ensure Due Date Adherence for these Quality Subsystems and report to management.
• Lead on-going efforts to improve GMED Quality System where applicable.
• Work effectively with the other GMED departments and corporate liaisons to ensure consistent/effective quality systems.
• Support site Quality system related improvement projects.
• Support CAPA and NC process
• Assures that non-conformance investigations and quality systems are in compliance with the good manufacturing practices as established in the code of local government regulations and company procedures.
• Utilize effective risk management tools to prevent unanticipated failure modes and ensure capability.
• Develop and implement appropriate Quality Procedures.
• Refers extraordinary situations to the quality assurance manager for final approval.
• Leads and supports the facility in identifying and eliminating compliance risks.
• Prepares quality agreements for suppliers, contractors and affiliates and schedules audits for compliance.
• Ensures that appropriate specifications and procedures are in place.
• Ensure effective change control.
• Ability to work under own initiative with minimum supervision.

 

Principal Duties and Responsibilities (essential functions) (current duties and/or responsibilities which account for more than 50% of job)

GENERAL
• Participate in project teams relating to Quality.
• Implement and ensure ongoing maintenance of the Internal Audit plan.
• Ensure active and thorough investigation of quality issues and effective corrective and/or preventive action.
• Ensure compliance with company policies and procedures.
• Provide guidance and recommendations involving the implementation of regulatory requirements (e.g. Quality System Regulation, EU MDD, ISO standards, etc.)

AUTHORITIES
• Reports any nonconformance's to the quality assurance manager.


BUSINESS PARTNERS
• Partner with MD manufacturing plants and key business partners.
• Partner with distribution centers and affiliates in the investigation/correction of process failures.
• Proactively communicate any changes in design or changes in process that could affect product.
• Ensure distribution centre and affiliate performance is monitored and addressed as needed.
• Provide leading metrics to Quality Assurance Manager. 

Mijn profiel

Education and/or Experience
• Appropriate Engineering, Life Science, Physical Science or Business Degree.
• PE Green Belt or Black Belt certified preferred.
• Related experience to demonstrate skills required. Other Skills and Abilities
• Demonstrated knowledge and application of QSR, MDD, ISO9001, 9002, 13485, 14971 and other international standards.
• Working knowledge of Good Distribution Practice.
• Fluency in English
• Practical experience of Lean Manufacturing and Lean tools.
• Computer Skills (Word, Excel, PowerPoint, Minitab, Visio, Project).
• Effective communication skills.
• Effective technical writing.
• Sense of urgency, intellectual curiosity, prudent risk-taking.

Aanbod

Talent moet in de watten gelegd worden. Daarom bieden we jou in ruil voor je kennis en engagement niet alleen een vast contract aan van onbepaalde duur. We staan ook in als je carrièreplanner en zoeken voor jou de beste kansen, opleidingen en groeimogelijkheden. Als aanvulling op je competitieve salaris krijg je een pak extralegale voordelen (dagvergoeding, groeps- en hospitalisatieverzekering, eventueel firmawagen, ...).

Over de vacature

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USG Professionals Science

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Het bedrijf

Quality Assurance Specialist

USG Professionals Science

USG Professionals, unit science, zet engineers flexibel in. Bedrijven doen snel en eenvoudig beroep op onze specialisten voor korte en lange termijn opdrachten in gespecialiseerde domeinen. Engineers vinden bij USG Professionals afwisseling, aantrekkelijke werkzekerheid en ruime opleidingsmo…

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