Functietitel: Quality Assurance Officer

Functieomschrijving:

Tasks

• Plan and execute quality assurance activities (document management, batch records and label issuance, batch record review, equipment and supplier qualifications etc.) including documentation.

• Monitor compliance with all applicable GMP and safety standards.

• Support the Qualified Person in his role, including audits and quality training.

• Write, review and approve documentation (SOP’s, manufacturing and quality instructions, validation of protocols and reports, non-conformities, change requests). Handle, distribute and archive controlled documents.

• Prepare data for trending (QRB, Annual Product Review) and support internal and external audits.

PharmaCell is an energetic, company acting as a Contract Manufacturing Organization (CMO) focused on cutting edge aseptic manufacturing cell, - and gene therapy products. The company works with European and US-based biotechnology companies on pre-clinical to commercial development projects and offers cell culturing process and assay development, Quality Control (QC)-testing and Good Manufacturing Practices (GMP) production services, as well as storage and distribution of clinical trial materials. The company is based in both Maastricht and Geleen (Netherlands), conveniently located at approximately one hour driving distance from Brussels, Antwerp, Cologne and Dusseldorf. We are a growing organization with young professionals with career possibilities including personal development.

Werkgever Naam: PHARMACELL

Werkgever adres:
PHARMACELL, Oxfordlaan 70 , NL-6229EV MAASTRICHT, NEDERLAND

Vorm van contact: Sondeijker

Job korte beschrijving:
Milieu-inspecteurs, inspecteurs arbeidshygiëne e.d.

Land: Nederland

Regio: NEDERLAND

Contractduur: Vast

Contract type: Voltijds

Ervaring: Tussen 2 en 5 jaar

Bron van jobaanbieding:
VDAB, Openbare diensten voor arbeidsvoorziening, België

Hoe toe te passen: Overig - zie vrije tekst