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Quality Control Executive

1 month ago

Kolhapur, India Unichem Laboratories Limited Full time

Experience - 9 to 12 Years Qualification - M.Sc. in Organic Chemistry/ Analytical Chemistry RESPONSIBILITIES Review in process materials, raw materials, Intermediates, recovered materials, finished products, tech transfer samples and cleaning verification / validation samples using current specification, STP, GTP and associated wet chemistry and instrumental techniques as appropriate. Prepare and review specifications, sampling instructions, test methods, analytical work records and other QC procedures. Review instrumental analysis results according to Matrix of analyst / microbiologist validation.Prepare and review training matrix & training plans. Prepare and review cleaning validation / verification, Method validation, Method verification, Method transfer protocols and reports. Prepare and review study protocols and reports related to Quality control activities. Prepare & analyze various quality documents including SOPs, validation protocols and reports. Timely review calibration for QC instruments like HPLC, Analytical Balance, Ultra Micro Balance, PH meter, Conductivity meter, UV spectrophotometer and refractometer etc. Prepare, review and keep track of yearly calibration schedule, monthly calibration planner & preventive maintenance schedule. Track and follow up on Method Validation, Verification, and Analytical Method Transfer activities Plan, execute and review of Method Validation, Verification & Analytical Method Manage daily planning activities and timely review of QC testing data Coordinate with service engineers during preventive maintenance and breakdown of QC instruments. Verify the quality and compliance of laboratory chemicals, Reagents and Indicators. Review logbook entries and daily monitoring activities. Monthly audit trial review for instruments. DESIRED SKILLS Proven experience in the Quality Control department of a reputable pharmaceutical organization. Hands on experience on QC Instrument Handling Complete understanding of operating instruments such as HPLC, GC, KF, IR, and pH meters. Strong analytical capabilities and learning attitude. Excellent interpersonal and communication skills