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15.0 - 20.0 years
12 - 20 Lacs
gandhidham
Work from Office
Key Responsibilities Lead, manage, and develop the QC function for pharma formulations as per company policies and regulatory requirements. Supervise and resolve lab incidents, deviations, change controls, OOS/OOT , and ensure robust documentation and root cause analysis. Oversee process validation, cleaning validation, hold time studies and related compliance activities. Establish and implement Stability Study protocols as per company SOPs, client specification, and all applicable quality standards. Handle product complaints & recall investigations in collaboration with QA and Production teams. Ensure compliance with current GMP, GLP, and regulatory guidelines for all laboratory operations. Maintain rigorous control of QC documentation, data integrity, and quality records. Coordinate external laboratory audits, regulatory inspections, and support internal audit programs. Train, mentor, and appraise QC staff for skills development and process improvements. Desired Candidate Profile Education: M.Sc / B.Sc / M.Pharm / B.Pharm (Chemistry/Pharmaceuticals/Relevant field) Experience: 15-20 years in Quality Control for pharma formulations (regulated plants preferred) Strong expertise in managing lab incidents, OOS/OOT, deviation, change control, validation activities, and stability protocols Well-versed with handling investigations for product complaints and recalls Familiar with global quality standards and client requirements Excellent leadership, team management, and communication skills Ability to collaborate cross-functionally and drive continuous improvement
Posted 5 days ago
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