QA Specialist
Job description
You will be part of a team of 4 Quality Specialists, 1 QMS Officer and 4 QA Officers. Together with your colleagues you will be responsible for the follow up of complaints and incidents; the administration in the QMS, the Root Cause investigation and the action plan with the relevant stakeholders. You will be playing an active role in the investigation and follow-up with the clients. Another interesting part of your job will be the audits and client projects with a QA impact, for example replacement of coolers or freezers. You will report to the QA Manager.
Challenge
- Translate and implement GDP-, GMP- and customer requirements into operational processes.
- Monitor compliance with GDP, regulatory and customer standards
- Develop procedures, provide training, and monitor Quality KPI
- Support and evaluate investigation reports, impact assessments, deviations and CAPA’s ensure timely closure (for complaints)
- Review and approve registrations for temperature, pest, and cleaning control programs.
- Coordination of risk assessment exercises.
- Internal audit performance
- Proactively advise and support the operational department
Profile candidate
- Education in Pharmacy, Bio-Engineering, Life Science, Industrial Engineering or similar
- QA Experience in Pharmaceutical, or related Industries
- Operational knowledge of GDP- and GMP-regulations
- High accuracy with urgency and changing priorities
- Excellent English language skills, both verbally and written
- Minimum conversational level of Dutch
- Excellent communication-, organisation- and analytical skills
- Team player
Company profile
With specific solutions developed for the pharmaceutical industry, including temperature control, special handling for vaccines and biologicals, packaging and direct delivery to patients and customers, our client provides logistics services for a number of large pharma and medical products customers.
You will be part of a team of 4 Quality Specialists, 1 QMS Officer and 4 QA Officers. The position is available for 32-40 hours a week, with the possibility to work 2 days from home, they offer excellent benefits and conditions.
