Key Responsibilities
Review analytical raw data, laboratory records, worksheets, and test reports for accuracy and compliance.
Review and approve RM, PM, In-Process, Finished Product, Stability, and Validation documentation.
Manage QMS activities including Deviations, OOS, OOT, CAPA, Change Control, and Risk Assessments.
Conduct investigations, root cause analysis, and ensure timely closure of quality events.
Review SOPs, specifications, protocols, reports, and other controlled documents.
Ensure compliance with GMP, cGMP, Data Integrity, and regulatory requirements.
Monitor QMS metrics, trends, and prepare periodic quality reports.
Coordinate with QC, QA, Production, and other departments for quality-related activities.
Support internal audits, customer audits, and regulatory inspections.
Ensure timely closure of review observations and maintain proper documentation.
Participate in continuous improvement initiatives and quality system enhancements.
Provide guidance and support to junior team members.

Pay: ₹500,000.00 - ₹650,000.00 per year

Advantages:
Health insurance
Leave encashment
Provident Fund

Work Location: In person

📌 Qc Executive Thane
🏢 Great Pacific Export
📍 Thane