Quality Control Manager

Umendra Life Sciences Pvt. Ltd. is looking for an experienced and hands-on Head – Quality Control to lead the QC function at our pharmaceutical manufacturing facility in Bavla, Ahmedabad.

We are looking for someone who has grown through core laboratory and QC operations and is comfortable taking end-to-end ownership of the department — from day-to-day laboratory functioning and release timelines to investigations, compliance, team development and regulatory readiness.

Key Responsibilities

• Lead the overall Quality Control function covering raw materials, packaging materials, in-process samples, finished products and stability testing
• Ensure timely sampling, testing, review and release of materials and products
• Manage and review OOS, OOT, laboratory incidents and investigations, ensuring scientifically sound root-cause analysis and CAPA
• Oversee stability studies, stability chambers, protocols, data evaluation and related documentation
• Ensure appropriate operation, calibration, qualification and maintenance of laboratory instruments including HPLC, GC, UV, FTIR and other QC equipment
• Drive laboratory compliance with GMP, GLP, data integrity and good documentation practices
• Oversee analytical method validation, verification and method transfer activities
• Ensure laboratory documentation, specifications, SOPs, STPs, worksheets and records remain current and compliant
• Lead, train and develop QC analysts, officers and managers while improving laboratory productivity and turnaround times
• Work closely with QA, Production, Warehouse, Regulatory Affairs and Engineering teams
• Support customer audits, regulatory inspections and responses to audit observations
• Maintain strong control over laboratory systems, records, reference standards, reagents, columns and consumables
• Identify recurring quality issues and drive practical improvements within the laboratory

Candidate Profile

• M.Sc. / B.Pharm / M.Pharm or equivalent relevant qualification
• Approximately 12–18 years of progressive experience in pharmaceutical Quality Control
• Strong hands-on experience in QC laboratory operations, rather than purely administrative quality roles
• Experience managing a QC team and taking independent responsibility for laboratory performance
• Strong knowledge of OOS/OOT investigations, stability, analytical instrumentation, method validation/transfer and data integrity
• Experience in a GMP-regulated pharmaceutical manufacturing environment is essential
• Exposure to USFDA or other regulated-market requirements will be strongly preferred
• Experience with topical / external preparations such as creams, ointments, gels, lotions or similar dosage forms will be an advantage
• Should be a practical, floor-oriented leader capable of balancing compliance with operational timelines

We are particularly interested in candidates who have spent a substantial part of their career inside the QC laboratory and manufacturing environment and are looking to take comprehensive ownership of the function.