
Senior Validation Consultant
1 week ago
Job Title: Senior CQV Trainer
A highly experienced professional is sought to lead global Commissioning, Qualification, and Validation (CQV) projects remotely. The ideal candidate will ensure compliance with regulatory requirements such as FDA, EU, and international standards including GxP.
Critical Responsibilities:
- Execute CQV activities for equipment, utilities, and computerized systems in accordance with industry standards.
- Develop and review CQV documentation, including URS, DQ, FAT, SAT, IQ, OQ, PQ, and risk assessments (e.g., FMEA).
- Implement validation master plans (VMP) and system impact assessments.
- Collaborate with cross-functional teams (engineering, QA, manufacturing, IT) to integrate CQV into capital and remediation projects.
- Conduct remote FAT/SAT support, data review, and validation strategy planning.
- Support Data Integrity assessments and 21 CFR Part 11 compliance for computerized systems.
- Ensure documentation meets GAMP 5, FDA, EMA, and ISO 13485 (for medical devices) requirements.
- Oversee remote execution of validation test protocols, ensuring deviations are captured and resolved.
Required Expertise:
- Bachelor's or Master's degree in Engineering, Life Sciences, or a related field.
- 10+ years of hands-on CQV experience in the pharma and/or medical device industries.
- Deep understanding of regulatory requirements.
- Expertise in GAMP 5, 21 CFR Part 11, and risk-based validation.
- Experience working in remote project environments.
- Proficient in using validation lifecycle software and document management systems.
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