Accountabilities:

1. 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.
2. Review Master Validation protocol and report for timely execution of validation batches and timely submission of documents in response to deficiencies.
3. Review annual product quality review report at units for completeness and data correctness to ensure compliance with cGMP requirements and audit readiness.
4. Review, upkeep, and issue regulated market technical agreements at the site for execution of batches as per customer requirements.
5. Receive and distribute approval certificates, dossiers (TDP & RAP), and development reports at the unit for smooth execution of new products.
6. Coordinate with auditors and site teams for regulatory and customer inspection/audit at the site to meet regulatory expectations and acquire GMP approvals.
7. 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.
8. 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.
9. Drive continuous improvement initiatives in CQA to facilitate adherence to cGMP.
10. 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.
11. 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

Application Link