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Quality Assurance Specialist Job

Eingestellt von Yoh

Gesuchte Skills: Support, Client

Projektbeschreibung

A QUALITY ASSURANCE SPECIALIST needed for a long-term contract opportunity with Yoh's client located in Raleigh, NC.

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- Quality Assurance
- CAPA, Deviations, Investigations

WHAT YOU'LL BE DOING:

- Responsible for the development and maintenance of quality procedures and systems related to Quality Assurance oversight
- Provide strategic and technical support for the Change Control program at the US FCC site in all cGMP compliance related matters, including assurance that all aspects comply with cGMP's, legal, regulatory requirements, and the V&D Quality Manual requirements.
- Ensures that all aspects of the Change control process comply with the requirements of the V&D Quality manual and meets all relevant cGMP regulatory requirements and are executed appropriately
- Responsible for the establishment of Quality Systems for QA oversight of manufacturing processes in relation to Change Control, Pharmaceutical Technical Complaints and Deviations.
- Acquire and maintain knowledge of current local and international regulatory and legislative requirements/trends to ensure that expert advice and appropriate technical support on all quality/compliance related matters are provided to the sites

WHAT YOU NEED TO BRING TO THE TABLE:

- Minimum of five (5+) years in Quality Assurance and/or in a GMP regulated environment within the pharmaceutical industry, preferable with experience in electronic Change control systems.
- Sterile product manufacturing knowledge and/or biopharmaceutical experience required.

BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:

- Ideal Background: Team is responsible for Quality Systems including deviation review and approval, change control management and Product Technical Complaints. Ideal candidate will have extensive experience with Trackwise Sentry system including Deviation and Change Control management as well as excel.

GET HIRED, APPLY NOW!

RECRUITER: Tonya Allen

Yoh, a DayJ2W: CLINICAL

MONJOB J2WNECLIN

Ref:

SFSF: LS

Projektdetails

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Yoh