Corporate Quality Assurance Manager - Thane
2 days ago
Job description
New Product Development (NPD):
Prepare and maintain NPD timetables to ensure timely project execution.
Review tracking and evaluate TP-NPD documentation for compliance and accuracy.
Documentation & Approvals:
Review and approve controlled documents including protocols, reports, and technical files.
- Review and approve different QMS (Quality Management System) elements as per compliance requirements.
- Review and approve corporate SOPs, ensuring alignment with current regulatory and site requirements.
Manage MRP and batch numbering issuance in line with manufacturing requirements.
Regulatory & Compliance:
Review and approve License Applications / SOI (Statement of Intent) as per Local FDA or FSSAI.
- Review and share UK Export Finished Product Certificates of Analysis (FP COA).
Review and approve regulatory declarations to ensure adherence to global standards.
Auditing & Compliance Assurance:
Conduct GMP audits of third-party Finished Product manufacturers to ensure compliance with regulatory and company standards.
- Conduct audits of Raw Material (RM) and Packaging Material (PM) vendors, prepare audit reports, and review compliance and CAPA effectiveness.
- Conduct ISO audits for internal departments, track findings, and ensure timely closure of audit observations.
- Participate in external / customer / Regulatory audits at LL sites and provide necessary support for compliance.
Internal MOPL site audits and compliance.
Quality Oversight:
Conduct and participate in vendor audits; prepare and track audit reports and CAPA implementation.
- Review and track APQR (Annual Product Quality Review) to ensure product compliance and continuous improvement.
Review and track Site Transfer / Tech Transfer activities for regulatory and operational compliance.
Reporting & Meetings:
Update and maintain MIS (Management Information System) for timely reporting.
Participate in and provide updates during Teams/virtual meetings with internal and external stakeholders.
Training & Leadership:
Conduct training sessions for cross-functional teams to ensure compliance and knowledge sharing.
- Perform responsibilities and decision-making tasks in the absence of HOD to ensure business continuity.
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