EFOR
CQV Engineer - Documentation
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Role Overview
We are seeking experienced CQV professionals to support a documentation review mission on site. The successful candidates will play a key role in ensuring that commissioning, qualification, and validation documentation meet regulatory and project standards.
Key Responsibilities
- Perform detailed reviews of CQV documents, including but not limited to protocols, reports, and supporting records.
- Verify documentation compliance with cGMP, GAMP, regulatory guidelines, and the site's internal quality standards.
- Identify gaps, inconsistencies, or non-conformances in existing documentation and recommend corrective actions.
- Collaborate with site CQV, engineering, and quality teams to clarify requirements or resolve discrepancies.
- Track and report progress of documentation reviews and findings.
- Support any remediation or additional documentation as required based on review outcomes.
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Key Requirements
- Demonstrable experience within CQV in the pharmaceutical or biotech sector, with particular focus on documentation review.
- Strong understanding of commissioning, qualification, validation procedures, and associated regulatory requirements (e.g., FDA, EMA).
- Excellent attention to detail; able to identify gaps and drive improvements in documentation.
- Familiarity with industry standards and best practices (e.g., cGMP, GAMP, ASTM E2500).
- Effective communication and teamwork skills.
- Track record in successful documentation remediation projects is a desirable.
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