My client is a leading Biotech who are currently in an exciting growth phase, with several innovative projects lined up for 2021, including one to treat COVID-19. Globally renowned for their innovations, they are searching for like-minded professionals who are searching for their next career challenge. At the moment, they are looking for a QA Validation Officer to join the team in the Netherlands, and assist with vital validation projects ASAP.
- Ensure all validation activities are in accordance with GMP guidelines
- Work according to established SOPs and remain up to date with current regulations
- Assist with ensuring QMS efficiency .
- You will directly engage with Engineering and manufacturing shop floor operations. This includes collaborating on validation strategy; providing cGMP guidance; document review and approval; and deviation handling.
- You will be involved in risk management; and the Quality review and approval of validation documentation (IQ, OQ, PQ, SAT etc)
- Equipment and system purchase support, URS review, evaluation of validation packages etc.
- Work with incident investigations to identify root cause (including causality vs correlation); identify CAPAs; and handle deviations.
- Application of cGMP change controls
- Support regulatory inspections including readiness exercises
- Bsc. or Msc. level in a relevant discipline (Biotechnology, engineering) or equivalent.
- Proven experience in a Validation role and/or Technical role
- Relevant experience in Quality role within Biotech or Biopharma environment.
- GMP experience is mandatory
- Experience with project management is highly beneficial
- Excellent knowledge of installation, instrument and equipment validation, pharmaceutical cGMP systems and international cGMP regulations and guidelines.
- You are a go-getter who is excited by taking on challenges and pushing yourself outside your comfort zone.
- You’re someone looking to take the next step in your career and work under highly driven people who are striving to build a highly trained Quality team and support your journey within the company.
- You are confident in your own capabilities, and have a growth mindset.
- 1 year contract, with intention to become perm
If you’re interested in the above description, please apply with your CV by clicking on the ‘apply’ button below. For further information, please contact Merel van Os at +31 (0)20 20 44 502 or by email at email@example.com