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vor 1 Monat
We are seeking a highly skilled Quality Assurance Specialist for QC to join our team at Randstad. As a key member of our quality assurance team, you will be responsible for ensuring the quality oversight and compliance of QC activities and the data integrity of QC analytical data in a timely manner.
Key Responsibilities:- QA Oversight on QC Analytical Data: Perform the QA review on QC analytical data, QC documentation, manage QC deviation, CCP, and CAPA as QA.
- Compliance of QC Activities: Provide QA support for QC activities, including new guidelines, new pharmacopeias versions, support the implementation of all QC projects, and perform quality on the floor for QC operations.
- Digitalization/Process Improvements: Propose and implement digitalized and more efficient solutions to improve processes in place within the department.
- Responsibility Backup: Each team member is the reference point of contact for one laboratory, and members of the team back up each other in case of absence as long as they are trained to the concerned activities.
- Participation in Inspections: Participate in health authorities and internal inspections as a subject matter expert, support QC laboratories during inspections, participate in inspection readiness planning meetings to prepare inspections, and implement appropriate CAPA plans after inspection.
- Education: Chemistry, biology, or pharmacy master degree with a minimum of 3 years of experience in the pharmaceutical industry.
- Experience: Experience in quality assurance, quality assurance operations is a plus.
- Expertise: Expertise in cGMP best practices.
- Skills: Good knowledge of laboratory equipment and software, such as Glims, Empower, Disco, is a plus.
- Language: Fluent in French and English.
- Collaboration: Having a team spirit and being collaborative are essential.
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