The Company
This client focuses on diseases where the need for new medicines is high and the cost high. This multinational is known as one of world’s biggest generic drug manufacturers. In the Netherlands, the core focus areas are neurology and pulmonology and the marketing of products for rheumatological conditions.
Role Description
As a QA Pharmaceutical Specialist, you serve as a key guardian of product quality and operational continuity within pharmaceutical manufacturing. You provide day-to-day support to production teams, lead investigations into deviations, and drive initiatives that enhance processes and maintain GMP compliance. Embedded within the Investigation & Improvement team, you contribute to thorough root cause analyses and foster a culture of continuous improvement across the production environment.
Responsibilities
- Being responsible for deviation & root cause management.
- Investigating, documenting, and assessing deviations occurring within the production process.
- Performing structured root cause analyses and contributing to the development of effective CAPAs.
- Recommending improvements to production techniques, products, and technologies.
- Evaluating the impact of deviations and determining whether production activities require adjustment or temporary stoppage.
Requirements
- Solid understanding of GMP requirements and pharmaceutical manufacturing processes; experience in aseptic production of injectables is a strong advantage.
- Proven experience conducting production investigations, performing root cause analyses, and participating in deviation assessments.
- A strong affinity for continuous improvement, operational optimization, and structured problem-solving within a manufacturing setting.
- Bachelor’s degree with several years of relevant experience, or a Master’s degree in Pharmacy, Life Sciences, or a related discipline.
Other information
Apply to our vacancy for more information. Looking forward to getting in touch!
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