Qureos Mentor

Mediwell Biotech

Key Responsibilities1. Laboratory Operations<ul><li>Manage QC laboratory activities for raw materials, intermediates, finished products, and stability samples.</li><li>Review and approve analytical reports, COAs, and test data.</li><li>Ensure calibration and maintenance of instruments like HPLC, GC, UV, FTIR, Dissolution Apparatus, etc.</li><li>Implement proper documentation as per 21 CFR Part 11, WHO-GMP, and GLP norms.</li></ul>2. Compliance &amp; Quality Systems<ul><li>Ensure compliance with DCGI, State FDA, WHO, and export regulatory requirements.</li><li>Review and maintain SOPs, STPs, and Specifications for all materials and products.</li><li>Handle OOS, OOT, deviations, and CAPA investigations.</li><li>Support internal and external audits and regulatory inspections.</li></ul>3. Team Leadership<ul><li>Supervise and train QC analysts, chemists, and microbiologists.</li><li>Allocate daily testing work and monitor laboratory productivity.</li><li>Conduct competency evaluation and skill enhancement sessions.</li></ul>4. Documentation &amp; Reporting<ul><li>Approve analytical results and maintain batch-wise QC release records.</li><li>Manage retention samples, stability studies, and trending reports.</li><li>Oversee documentation control as per data integrity principles (ALCOA+).</li></ul>5. Cross-Functional Coordination<ul><li>Coordinate with QA for batch release and market complaints.</li><li>Collaborate with Production for in-process controls and process validations.</li><li>Work with Procurement for vendor qualification of raw materials and packaging materials.</li></ul>Qualifications:<ul><li>Education: M.Pharm / B.Pharm / M.Sc (Chemistry / Microbiology)</li><li>Experience: Minimum 8&ndash;12 years in QC (pharmaceutical formulations), with at least 3 years in a managerial/supervisory role.</li></ul>Knowledge Required:<ul><li>HPLC, GC, UV, dissolution, and other analytical techniques</li><li>WHO-GMP, ICH, and GLP guidelines</li><li>Stability studies, LIMS, and data integrity</li></ul>Job Types: Full-time, PermanentPay: &#8377;60,000.00 - &#8377;90,000.00 per monthWork Location: In person

QC Manager

Join Mediwell Biotech and explore 1   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Mediwell Biotech

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QC Manager