Quality Assurance officer(Assistant Manager)

Job Description:

There is a wide variety of roles within Quality Assurance (QA) in pharma and food. A QA professional may be involved in Good Clinical Practice (GCP), Good Distribution Practice (GDP) or Good Manufacturing Practice (GMP). Often these functions are generally expressed as GxP. The majority of roles Herakles Pharma Staffing recruits for are linked to the manufacturing of medicinal products. As a QA Officer or QA manager GMP you may be involved in batch review, approval of incoming raw material requests and subsequent release, change control and validation related activities. All information and actions are documented in appropriate quality systems. Usually, there is a close collaboration between QA GMP and supply chain in order to assure the quality and distribution of the medicinal products and quality systems.

Activities and responsibilities of a Quality Assurance Officer:

• Review of paper and electronic batch records on completeness, clarity and GMP compliance;
• Review of raw material related documentation and release of raw materials;
• Provide quality support for the development of appropriate Corrective and Preventative Actions (CAPA’s);
• Provide advice to requesting departments regarding GMP aspects;
• Review and approve QA controlled documentation (SOP’s, batch records, working instructions);
• Assessing change requests on consistency, relevance, GMP compliance and clarity;
• Review and preparation of batch release documentation;
• Support in continuous improvement activities.

Your background and profile:

• BSc or MSc in biopharmaceutical or biomedical science, chemistry, pharmacy or equivalent;
• Preferably some years of work experience in the pharmaceutical or food industry;
• Preferably up to date knowledge of current GMP regulations;
• Good communication skills in Dutch and English;
• Critical and highly accurate;
• Able to work independently as well as working well within a team.