- Implement Site System Audits and Walk-Through Audits in the various production and quality departments.
- Evaluation of corrective and preventive actions (CAPA) with the Sub-System Owners and follow-up of good implementation.
- Providing support in the preparation of inspections by government agencies (IGZ, FDA, …) and audits by customers and contract partners.
- Provide support in coordinating the answers / corrective and preventive actions formulated by MSD Haarlem on the observations made by government agencies and third parties.
- Accurate and regular follow-up of the implementation of corrective and preventive actions following government inspections and other audits.
- Create and follow up metrics
- Execution of trend reports of audits and observations
- Contributing to a growing quality awareness within the business environment of MMD; propagating the quality system and being a representative for Quality within different systems.
- Minimum HBO background (preferably pharmaceutical, process engineering, or chemical background), supplemented with at least 3 years of relevant work experience within a quality or production environment
- Experience with performing audits / self inspections is an advantage
- Knowledge of and experience with pharmaceutical-technical aspects, GMP and GDP
- Persuasiveness, result-oriented, accurate, flexible and independent
Good administrative skills
- Good communication skills in both word and writing, in Dutch and English
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