Work as an Operations QA Officer in a GMP-regulated production environment in Gorinchem. Support shop-floor teams, investigate deviations and drive lasting improvements. Permanent contract, competitive salary and a rotating two-shift schedule.
The role
At our client company in Gorinchem, you will work as an Operations QA Officer in a GMP-regulated production environment. You will connect Quality and Operations, remain visible on the shop floor and work closely with operators, technologists, shift managers and colleagues in QC and QA. You will identify quality risks, support production and help resolve deviations effectively.
Your responsibilities
- Support Operations and monitor compliance with GMP requirements on the shop floor.
- Act as the point of contact for quality questions in the production environment.
- Identify, record and follow up deviations and complaints, including CAPA processes.
- Conduct and coordinate Root Cause Analyses using methods such as Five Whys and 8D.
- Oversee batch documentation to support an efficient quality release process.
- Coordinate line clearances between batches and production campaigns.
- Identify trends and translate analyses into lasting improvement actions.
- Advise production and quality teams on practical GMP solutions and help strengthen the quality culture.
- Conduct internal audits and support customer audits and inspections. Follow up audit findings and support corrective and preventive actions.
- Translate GMP and GDP requirements into daily practice and prioritize work without compromising quality or compliance.
Schedule
You will work on a rotating two-shift schedule with early and late shifts. The schedule may possibly be extended to a five-shift system in the future.
What you bring
- MBO+ level with relevant work experience, or a completed relevant HBO degree, for example in Pharmacy, Life Sciences, Chemistry, Biotechnology or a related field.
- Experience in a GMP-regulated environment and in QA, QC, production or a similar quality-focused role.
- Experience investigating deviations, handling complaints, managing CAPA processes and conducting Root Cause Analyses.
- Practical knowledge of GMP and the ability to apply it in an operational setting.
- Experience preparing quality documentation and reports for audits and inspections.
- Strong communication skills and the ability to engage colleagues in change.
- A pragmatic, solution-oriented approach and an analytical, curious and structured way of working.
- An approachable, visible working style and willingness to work in a two-shift schedule.
- A good command of Dutch.
- Experience in the pharmaceutical industry, pharmaceutical manufacturing, pharmacy compounding, QC laboratories or comparable GMP environments is an advantage. Experience with audits and inspections is also an advantage.
What is offered
- A permanent contract and a competitive salary.
- A varied role with responsibility close to operations and the opportunity to contribute to quality, compliance and operational performance.
- A mix of operational and analytical work in close collaboration with production and quality.
- Professional development opportunities in a professional, informal and collegial environment focused on collaboration, sharing knowledge and continuous improvement.