Biotech Qualification Expert

Vor 2 Tagen


CorsiersurVevey, Schweiz Randstad Professionals Vollzeit

We are looking for an experienced Biotech Qualification Expert to join our team at Randstad Professionals. In this role, you will be responsible for providing QA expertise for various aspects of our Biotech drug substance plant, including Equipment Qualification/Requalification, Sterilization qualification, Cleaning Validation, Raw Material Qualification, Process & Analytical Validation, and Computerized System Validation.

Main Responsibilities:
  1. Develop and implement qualification/validation strategies to ensure GMP compliance
  2. Review and approve protocols and reports to guarantee accuracy and completeness
  3. Collaborate with cross-functional teams to identify risks and develop mitigation plans
  4. Act as Quality Subject Matter Expert on specific topics, providing guidance and expertise to team members

This position requires a strong understanding of cGMP regulations and health authority expectations. Experience in Data Integrity is also desirable. If you have a passion for quality assurance and a track record of success in the pharmaceutical industry, we encourage you to apply.



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