CQV QA and Validation Specialist
1 week ago
CQV Quality Assurance Role
This contract position involves working with a biopharmaceutical company to create innovative life-transforming therapeutic products. Our team requires a skilled CQV QA Specialist to ensure compliance with Good Manufacturing Practice (GMP) and regulatory standards.
About the Position:
- Oversight of CQV Activities: Ensure that all CQV activities meet required standards.
- Document Review: Approve qualification protocols, reports, and risk assessments.
- Equipment Qualification Support: Oversee the qualification of analytical instruments.
- Quality Event Management: Resolve deviations, change controls, and CAPA.
- Compliance Monitoring: Monitor adherence to FDA, EMA, and internal quality procedures.
- Risk Assessment Conduct: Identify and address risks related to systems and processes.
- Documentation Control Support: Maintain timely QA review of all GMP-related documents.
- Team Collaboration: Support validation strategies and timelines across teams.
About You:
- Education: BSc in Science or Engineering.
- Experience: At least 5 years of relevant experience in the pharmaceutical industry in a similar or related role.
- Skills:
- Validation
- QA Oversight
- GMP
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