About the role
Global Calcium Pvt. Ltd., a leading pharmaceutical company, is seeking a Quality Control Analyst with 3–5 years of experience in API (Oncology). The ideal candidate will be responsible for analytical testing, documentation, and ensuring compliance with cGMP and regulatory standards. This position is critical in maintaining quality across all stages of production.
Key Responsibilities
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Perform analysis of raw materials, intermediates, finished products, in-process materials, packing materials, and stability samples
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Operate and maintain analytical instruments:
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HPLC (Shimadzu, Agilent, Empower, Chromeleon)
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GC, IR, UV, Moisture Balance, Karl Fischer (KF), Potentiometric Titration
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Conduct analytical investigations including:
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System Suitability Tests
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Laboratory Investigations
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OOS (Out of Specification), OOT (Out of Trend) analysis
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Root Cause Analysis and implementation of CAPA
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Ensure adherence to GMP, GLP, and applicable regulatory standards (FDA, WHO, ICH)
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Maintain accurate documentation and data integrity in compliance with audit and inspection requirements
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Collaborate with QA, ADL, R&D, and Production teams for process improvements
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Identify documentation gaps and suggest improvements to ensure compliance and efficiency
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Support internal and external audits through proactive documentation and team coordination
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Strong analytical and documentation skills
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In-depth knowledge of cGMP/GLP and regulatory guidelines
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Proficiency in using analytical software (LabSolutions, Empower, Chromeleon)
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Detail-oriented with a passion for quality and data accuracy
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Excellent problem-solving and root cause analysis skills
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Team player with good communication and interpersonal abilities
Experience: 3 to 5 years in Quality Control
Educational Qualification : MSc / BSc in Chemistry / Analytical Chemistry
Industry: Pharma Bulk Drug /API/API oncology