Accountabilities
- Regulatory Responses: Collate, review, and provide work plans on received deficiencies to the Head Office for timely responses to regulatory authorities.
- Validation Protocols: Review master validation protocols and reports to ensure timely execution of validation batches and submission of documents.
- Annual Product Quality Review: Review annual product quality review reports 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 the site to execute batches as per customer requirements.
- Approval Distribution: Receive and distribute approval certificates, dossiers (TDP & RAP), and development reports at units for smooth execution of new products.
- Audit Coordination: Coordinate with auditors and site teams for regulatory and customer inspections/audits at the site to meet regulatory expectations and acquire GMP approvals.
- Audit Observations: Prepare the final draft of compliance to audit observations and ensure alignment with cGMP requirements to avoid regulatory actions and facilitate continual improvements.
- Data Compilation: Collect, compile, and review raw data for timely submission of MHRA, UK interim update documents to corporate, 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.
- Submission Accuracy: Execute on-time and error-free submissions by reviewing product licenses, all certificates for product registration and tenders, staff approvals, and other applications to adhere to legal requirements.
- Inspection Support: Support in CDSCO and state FDA inspections to be GMP compliant and obtain product licenses and FDA staff approvals by ensuring cross-functional interaction.
