To perform the Qualification and Quality System audit to ensure these manufacturing facilities/organizations are maintaining quality standards in compliance with cGMP standards and regulatory requirements
Area of Responsibility:
- Ensure audit compliance received from auditee and verify appropriateness of CAPA, so as to close the audit in stipulated time line
- Conduct audits to ensure compliance level according to applicable cGMP / Regulatory Requirements. To identify non-conformance with respect to Quality / Systems / Procedures / Operation against the respective regulatory requirement.
- Ensure re-audits are executed for under observation/conditionally approved categorized vendors, and ensure CAPA re-audits are executed in case of critical observations as applicable within required timelines as per respective procedures.
- Minimum of a master's degree in Pharmacy or pharmaceutical related science
- Minimum of 12 years of experience Pharmaceutical Quality Assurance and has sufficient experience in conducting GMP Audits
- Up to 80% travel