We are looking for a Senior QC Officer (HPLC / GC) to handle instrumental analysis and testing at our WHO-GMP certified manufacturing plant. You will be responsible for testing raw materials, finished products, and stability samples using HPLC, GC, and wet chemistry, ensuring strict adherence to cGMP, GDP, and ALCOA+ principles.
Key Responsibilities
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Instrumental Analysis: Perform routine testing of raw materials, in-process, and finished goods using HPLC and GC as per standard test procedures.
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Stability Testing: Execute stability studies, monitor sample withdrawal schedules, and perform analytical testing as per ICH guidelines.
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Method Validation & Transfer: Support analytical method validation, verification, and routine calibration of chromatography instruments.
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Documentation & Compliance: Maintain complete testing records, review analytical raw data, and prepare COA following ALCOA+ and GDP norms.
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OOS / OOT Handling: Identify and report OOS/OOT results and laboratory deviations, supporting thorough root cause investigations.
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Calibration & Maintenance: Carry out routine calibration and preventive maintenance of HPLC, GC, UV, and analytical balances.
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Chemicals & Standards: Maintain working standards, reference standards, and reagent preparation logs with timely tracking of expiry dates.
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Lab Coordination: Coordinate with QA for batch release testing and maintain the quality control laboratory in an audit-ready state (GLP).
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Experience: 2–3 years of hands-on experience in Quality Control instrumental analysis (HPLC/GC) in a pharma manufacturing facility.
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Education: B.Pharm / M.Pharm / M.Sc (Chemistry / Analytical Chemistry).
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Skills:
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Hands-on expertise in operating and troubleshooting HPLC and GC instruments.
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Proficient in software like Empower / ChemStation and basic MS Excel.
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Strong understanding of GLP, cGMP, GDP, data integrity, and ALCOA+ standards.
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Solid knowledge of pharmacopoeial standards (IP/USP/BP) and test methods.
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Personal Traits:
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High attention to detail and precise analytical skills.
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Disciplined, reliable, and committed to data integrity.
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Good team player with clear communication.
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Competitive salary + performance incentives
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Health insurance (as per company slab)
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PF / ESIC as per norms
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Subsidised meals & company transport
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Stable, quality-driven work culture
