We are looking for Quality Assurance (QA) specialist with broad experience in the pharmaceutical industry to help support the QA team in a temporary position. As the QA specialist you will act as a lead auditor in the internal audit program, execute quality investigations and maintain the site master file, all under GMP.
Job Description
The Quality Assurance department is a fast-developing department, where they are currently working on the development of a new vaccine for COVID-19. The QA team is responsible for overseeing and supporting the quality systems, projects and facilities.
The QA specialist collaborates in a matrix environment to drive handling of quality data. You will represent the Quality department when needed and will be involved in cross-departmental meetings.
Furthermore within the internal audit program you will play a key role, acting as a lead auditor or co-auditor. Maintaining the Site Master File, performing risk assessments and maintaining / improving upon the Site Risk Register, executing quality investigations such as CAPA management, change controls are also part of this challenging job.
Responsibilities
- Collaborates in a matrix environment to drive handling of quality data (intrinsic quality)
- For the internal audit program, you will take on the role of lead auditor or co-auditor
- Maintain the Site Master File
- Assess the site risks and maintain and improve the Site Risk Register
- Support and execute quality investigations (CAPA management) and change controls in a GMP environment
- Represent the Quality department when needed
Requirements
- At least a HLO/WO degree with a pharmaceutical, biological background
- Available for a temp position of 3-6 months
- At least 5 years of experience within quality assurance
- Extensive knowledge of GMP
- Experience with Tableau/ and Trackwise is considered a big plus
- Knowledge of Risk management, RCA, CAPA management and Change Control Process
- Lead auditor or experienced with being a co-auditor in a GMP environment (by preference in vaccines)
- Language: English, knowledge of Dutch is an advantage
Benefits
- Contract: Temporary contract via Oxford, expected term is 3-6 months
- Salary: €4000- €6800 gross monthly based on a full-time position
- Holidays: 25
- Working hours: full-time, 32 hours discussable
- Region: Leiden
- Vacancy number: 17216
Oxford Global Resources is het grootste recruitmentbureau binnen de vakgebieden Science, Engineering en IT. Al onze recruiters hebben zelf een relevante achtergrond binnen deze gebieden en helpen je graag bij het vinden van de perfecte baan in ons uitgebreide netwerk.
Als gespecialiseerde partij hebben wij een groot aanbod aan laboratorium vacatures op het gebied van Quality Control (QC) en Research &Development (R&D) binnen diverse sectoren, waaronder de Farmaceutische industrie, Biotechnologie, Contract Manufacturing, Contract Research, Voedingsmiddelenindustrie, Chemie, Milieu en Plantensector.
Oxford is altijd op zoek naar talent met expertise op het gebied van Biotechnologie, Immunologie, Biochemie, Virologie, Microbiologie, Moleculaire Biologie, Life Science, Analytische Chemie, Fysische Chemie, Polymeerchemie, Petrochemie en Diagnostiek. Wij komen graag in contact met kandidaten die ervaring hebben met een of meerdere van de volgende technieken: USP (Upstream Processing) DSP (Downstream Processing), Bioprocesses, viruskweek, celkweek, ELISA, FACS, Western Blot, SDS-page, PCR, RT-PCR, qPCR, kloneren, sequencing, eiwit zuivering, purificatie, HPLC, UPLC, chromatografie, fysische chemie, viscositeit, smeltpunt, pourpoint, pH, XRF, GC, GC-MS, LC, LC-MS, ICP ICP-MS, AAS, UV, titraties, Karl Fisher, formuleren, steriliteit, determinaties, bioburden, environmental monitoring, LIMS, GMP, GLP, GCP, GDP, ISO17025.
Vind je deze vacature interessant? Of ben jij op zoek naar een functie op MLO, HLO, BSc, WO, MSc of PhD en heb je interesse in de vacature laboratorium Assistent, Laborant, Laborant monster voorbereiding, Analist, Technician, Assistant Scientist, Associate Scientist, Scientist, Manufacturing Specialist, Process Engineer, Validatie Engineer, QA (Quality Assurance) Officer, RA (Regulatory Affairs) Officer, Supervisor, Teamleider, Afdelingshoofd, Hoofd Laboratorium, Manager, Director, etc. Neem dan direct contact met ons op!
