Accountabilities:
- Deficiency Response: Collate, review and provide required work plans on received deficiencies to HO in order to respond to regulatory authorities in a timely manner.
- Validation Protocol: Review Master Validation protocol and report for timely execution of validation batches and timely submission of documents in order to respond for deficiencies.
- Product Quality Review: Review annual product quality review report at units for completeness and data correctness to ensure compliance with cGMP requirements and audit readiness.
- Technical Agreements: Review, upkeep and issue regulated market technical agreements at site for execution of batches as per customer requirements.
- Approval Distribution: Receive and distribute approval certificates, dossiers (TDP & RAP) and development reports at unit for smooth execution of new products.
- Audit Coordination: Coordinate with auditors and site teams for regulatory and customer inspection/audit at site to meet regulatory expectations and acquire GMP approvals.
- Audit Compliance: Prepare final draft of compliance to audit observation and check whether it is in line with cGMP requirements to avoid regulatory action and ensure continual improvements.
- Data Compilation: Collect, compile and review raw data and finalize the same for timely submission of MHRA, UK interim update documents to corporate as per agency requirements by tracking interim updates at a site level for risk-based inspection planning.
- Continuous Improvement: Drive continuous improvement initiatives in CQA to facilitate adherence to cGMP.
- Errorless Submissions: Execute on-time and errorless submissions by reviewing product licenses, all certificates for product registration and tender, staff approvals, and other applications to adhere to legal requirements.
- Regulatory Support: Support in CDSCO and state FDA inspection to be GMP compliant and get product licenses, FDA stall approvals by ensuring cross-functional interaction.
