RESPONSIBILITIES Responsible for review of In process, 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. Responsible for review of instrumental analysis as per the Matrix of analyst / microbiologist validation. Preparation and review of training matrix & training plan. Prepare and review cleaning validation / verification, Method validation, Method verification, Method transfer protocols and reports. Prepare and review study protocol and report for Quality control activities Preparation & review various quality documents such as SOPs, validation protocols and reports. Responsible for review of calibration of QC instruments like HPLC, Analytical Balance, Ultra Micro Balance, pH meter, Conductivity meter, UV spectrophotometer and refractometer etc Responsible for preparation, review, tracking of yearly calibration schedule, monthly calibration planner & preventive maintenance schedule. Ensure the tracking and follow up for the Method Validation, Verification & Analytical Method Transfer Activity. Planning and Execution of Method Validation, Verification & Analytical Method Coordinate with service engineer during preventive maintenance and breakdown of QC instruments. Responsible for verification of Laboratory chemicals, Reagents and Indicators. Review of logbooks in Quality Control Department and Responsible for monthly audit trial review for instrument. WORK RELATIONS Interfaces: Internal Quality Assurance, Quality Control, EHS, HRA, Warehouse, Engineering Interfaces: External External Vendors. DESIRED SKILLS Must have experience in Quality Control department in reputed pharma organizations. Should have hands on experience of Instrument Handling Strong knowledge of operating HPLC, GC, KF, IR, pH Meter etc. One Should Manage day to day Planning Should review method validation, Verification & Analytical Method Transfer Activity. One should timely review of calibration / verification of instruments. Ensure timely review preventive maintenance of instruments. Should review of records of QC testing. One should Timely review of logbook entries & daily monitoring activities.
