CQV/Operational Readiness Specialist

Location: Switzerland
Sector: Pharmaceutical

About the Role:
We are seeking a highly skilled CQV/Operational Readiness Specialist to join our client’s team in Switzerland. This critical role supports the readiness and operational success of pharmaceutical manufacturing operations, ensuring compliance, quality, and validation (CQV) processes meet stringent regulatory standards. The ideal candidate will possess a deep understanding of the pharmaceutical production lifecycle, from design through to execution, with a focus on maintaining quality, safety, and operational efficiency.

Key Responsibilities:

• Commissioning, Qualification, and Validation (CQV): Lead and manage CQV activities across various phases of project execution, including FAT, SAT, IQ, OQ, and PQ, to ensure readiness and compliance of manufacturing equipment and systems.
• Operational Readiness: Develop and implement operational readiness plans, coordinating closely with project teams, engineering, and manufacturing to support seamless integration of new processes and systems.
• Documentation and Compliance: Prepare and review high-quality documentation, ensuring adherence to GMP, GxP, and all relevant regulatory guidelines. Oversee the generation, review, and approval of validation protocols and reports.
• Cross-functional Collaboration: Work with cross-functional teams, including QA, QC, and engineering, to troubleshoot issues, ensure alignment, and promote continuous improvement.
• Risk Assessment and Mitigation: Conduct thorough risk assessments to identify and mitigate potential operational issues, ensuring a robust and compliant validation process.

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or a related field. Advanced degree preferred.
• 5+ years of experience in CQV within the pharmaceutical or biotechnology industries.
• Strong knowledge of GMP, GxP, and regulatory requirements specific to the pharmaceutical sector.
• Proven experience in managing CQV activities in complex project environments.
• Excellent communication, documentation, and problem-solving skills.
• Fluency in English is required; proficiency in German or French is an advantage.

What We Offer:

• Competitive compensation package
• Opportunity to work with a leading pharmaceutical organization in Switzerland
• Supportive and collaborative work environment
• Opportunities for professional growth and development

How to Apply:
If you meet the qualifications and are passionate about ensuring operational readiness and compliance within the pharmaceutical industry, we invite you to apply.

Application Deadline: 12/12/2024