Quality Assurance Validator
6 days ago
This critical role ensures compliance with Good Manufacturing Practice (GMP) standards and maintains a validated state across site operations.
- Review qualification and validation documentation for equipment, systems, facilities, and utilities to ensure adherence to GMP standards.
- Provide QA oversight during execution of qualification, requalification, and validation activities to guarantee quality and compliance.
- Develop the Site Validation Master Plan in alignment with regulatory expectations to ensure efficient and effective validation processes.
- Coordinate with manufacturing and engineering teams to ensure timely completion of validation tasks and minimize downtime.
- Lead investigations into deviations or deficiencies related to qualification activities, and drive corrective actions to maintain a validated state.
To succeed in this role, candidates should possess:
- A degree in a scientific discipline such as chemistry, biology, or engineering.
- Proven working years in a GMP-regulated pharmaceutical or biopharmaceutical environment with a strong understanding of validation lifecycle principles.
- Strong knowledge of validation lifecycle principles, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Experience with Site Validation Master Plan development and implementation.
Candidates should also have excellent collaboration skills, strong communication, and attention to detail to work effectively with cross-functional teams.
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