Location: Goa, India
Req ID: 81897
Department: Quality
Employment Type: Permanent
Job Purpose:
Ensure site compliance with company quality policies and regulatory guidelines. Prepare master validation protocols and reports.
Accountabilities:
- Regulatory Compliance:
- Collate and review work plans for received deficiencies.
- Respond to regulatory authorities promptly.
- Validation Protocols:
- Review master validation protocols and reports.
- Ensure timely execution of validation batches and submission of documents.
- Annual Reviews:
- Review annual product quality reports.
- Ensure compliance with cGMP requirements and audit readiness.
- Technical Agreements:
- Maintain and issue regulated market technical agreements.
- Ensure batch execution as per customer requirements.
- Documentation Management:
- Distribute approval certificates, dossiers (TDP & RAP), and development reports.
- Ensure smooth execution of new products.
- Audit Coordination:
- Coordinate with auditors and site teams for inspections.
- Acquire GMP approvals.
- Compliance Checks:
- Prepare final drafts of compliance to audit observations.
- Ensure alignment with cGMP requirements.
- Data Management:
- Collect, compile, and review raw data.
- Finalize MHRA, UK interim update documents.
- Track interim updates for risk-based inspection planning.
- Continuous Improvement:
- Drive initiatives to facilitate adherence to cGMP.
- Timely Submissions:
- Review product licenses and certificates.
- Ensure error-free submissions for product registration, tenders, and other applications.
- Inspection Support:
- Support in CDSCO and state FDA inspections.
- Ensure cross-functional interaction to achieve GMP compliance and approvals.
Education Qualification:
- B. Pharma / M.Sc
Relevant Work Experience:
- 2 years in the Quality Assurance department
Competencies/Skills:
- Collaboration
- Innovation
- Accountability
- Empathy
- Agility
- Strong Domain Knowledge
- People Management
Job Location: Goa, India
