08 Sep
|
Umendra Life Sciences
|
Surat
08 Sep
Umendra Life Sciences
Surat
Job Description
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.
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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.
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Key Responsibilities
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- Lead the overall Quality Control function covering raw materials, packaging materials, in-process samples, finished products and stability testing
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- Ensure timely sampling, testing, review and release of materials and products
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- Manage and review OOS, OOT, laboratory incidents and investigations , ensuring scientifically sound root-cause analysis and CAPA
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- Oversee stability studies , stability chambers, protocols, data evaluation and related documentation
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- Ensure appropriate operation, calibration, qualification and maintenance of laboratory instruments including HPLC, GC, UV, FTIR and other QC equipment
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- Drive laboratory compliance with GMP, GLP, data integrity and good documentation practices
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- Oversee analytical method validation, verification and method transfer activities
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- Ensure laboratory documentation, specifications, SOPs, STPs, worksheets and records remain current and compliant
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- Lead, train and develop QC analysts, officers and managers while improving laboratory productivity and turnaround times
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- Work closely with QA,
Production, Warehouse, Regulatory Affairs and Engineering teams
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- Support customer audits, regulatory inspections and responses to audit observations
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- Maintain strong control over laboratory systems, records, reference standards, reagents, columns and consumables
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- Identify recurring quality issues and drive practical improvements within the laboratory
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Candidate Profile
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- M. Sc. / B. Pharm / M. Pharm or equivalent relevant qualification
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- Approximately 12–18 years of progressive experience in pharmaceutical Quality Control
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- Strong hands-on experience in QC laboratory operations , rather than purely administrative quality roles
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- Experience managing a QC team and taking independent responsibility for laboratory performance
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- Strong knowledge of OOS/OOT investigations, stability, analytical instrumentation, method validation/transfer and data integrity
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- Experience in a GMP-regulated pharmaceutical manufacturing environment is essential
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- Exposure to USFDA or other regulated-market requirements will be strongly preferred
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- Experience with topical / external preparations such as creams, ointments, gels, lotions or similar dosage forms will be an advantage
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- Should be a practical, floor-oriented leader capable of balancing compliance with operational timelines
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We are particularly interested in candidates who have spent a substantial part of their career inside the QC laboratory and manufacturing setting and are looking to take comprehensive ownership of the function.
📌 Quality Control Manager (Surat)
🏢 Umendra Life Sciences
📍 Surat