
Compliance Specialist
1 week ago
Seeking a detail-oriented Validation Specialist to oversee validation activities, ensuring compliance with industry regulations.
- Review and validate IOQ documentation generated by vendors.
- Develop and execute qualification plans for equipment and instruments in aseptic fill finish facilities.
- Support the review and validation of documentation from calibration and thermal mapping vendors.
- Evaluate validation requirements for new equipment, change controls, and emerging trends.
- Monitor project progress and provide updates on validation status.
- Collaborate with project managers to ensure project schedules are met.
- Assess current practices to ensure compliance with cGMP standards.
- Develop and implement procedures, reports, and results for compliance.
- Coordinate SDLC documentation and review/validation protocols plant-wide.
- Review and approve project change controls.
- Contribute to the development of company validation standards.
Award-winning company is an equal opportunities employer.
Seniority level- Mid-Senior level
- Contract
- Engineering and Production
- Pharmaceutical Manufacturing and Biotechnology Research
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