Accountabilities:
- Collate, review, and provide required work plans on received deficiencies to the Head Office in order to respond to regulatory authorities in a timely manner.
- Review Master Validation protocol and report for timely execution of validation batches and timely submission of documents in response to deficiencies.
- Review annual product quality review report at units for completeness and data correctness to ensure compliance with cGMP requirements and audit readiness.
- Review, upkeep, and issue regulated market technical agreements at the site for execution of batches as per customer requirements.
- Receive and distribute approval certificates, dossiers (TDP & RAP), and development reports at the unit for smooth execution of new products.
- Coordinate with auditors and site teams for regulatory and customer inspection/audit at the site to meet regulatory expectations and acquire GMP approvals.
- Prepare the final draft of compliance to audit observation and ensure it is in line with cGMP requirements to avoid regulatory action and ensure continual improvements.
- 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.
- Drive continuous improvement initiatives in CQA to facilitate adherence to cGMP.
- Execute on-time and errorless submissions by reviewing product licenses, all certificates for product registration and tenders, staff approvals, and other applications to adhere to legal requirements.
- Support in CDSCO and state FDA inspections to be GMP compliant and get product licenses, FDA stall approvals by ensuring cross-functional interaction.
Education Qualification:
- B. Pharma/M.Sc
Relevant Work Experience:
- 2 years of experience in the quality assurance department
Competencies/Skills:
- Collaborate to Succeed
- Innovate to Excel
- Perform with Accountability
- Lead with Empathy
- Act with Agility
- Strong Domain Knowledge
- People Management
Job Location: Goa
