Quality Specialist

Responsibilities 1. Roles & responsibilities are as a QC-Reviewer in chemical analysis section. 2. Review of followings but not limited to: Analytical Data of Raw material, In-process, Intermediates, Finished Products and Stability, Certificate of Analysis (COA), Analytical Method Transfer and Analytical Method Verification Data, Calibration records, Working standard qualification documents, instrument usage log books, Impurity standard / Primary standard / Reference standard / Working standard usage log, specifications, Standard Test Procedures,water analysis report,Lab Reagent and volumetric solution. 3. Review of In-process/Raw material/Finished material etc. Analysis. 4. Coordinate with manufacturing blocks to plan the analysis of reaction monitoring samples in shifts. 5. Responsible to ensure the policy of rounding off followed in reported results. 6. Role of “Reviewer” in, Lab solution ,Lab-India software (or equivalent) in Non-CDS software. 7. Responsible to maintain cleanliness and GLP compliance of laboratory 8. To provide the observations in Observation Compliance Form, if found, during Review and ensure its completion and compliance. 9. .Responsible to follow Good Laboratory Practices (GLP) and Good Documentation Practices (GDP) in Quality Control Department. 10. Responsible to conduct the preliminary investigations and provide further recommendation in Laboratory incidence & OOS. 11. Provide on job training to subordinates and involve in their development. 12. Develop interpersonal skills and self development by getting periodic training as per requirements Chemical analysis of RM/PM/FP/Stability samples. 13. Perform analysis & Calibration of instrument Analytical balance, pH Meter,Karl Fisher Titrator, Melting Point Apparatus, Potentiometer, UV-Spectrophotometer,FTIR, HPLC/UPLC as and when required. 14. Performed HPLC/UPLC analysis for FP/RM/Stability/In-process etc. . 15. Maintain & review Temperature/Humidity record. 16. Maintain entry log of RM/PM/FP/In-process as and when required. 17. Initiate and Help in investigation of OOS,Incidence & deviation. 18.Follow the SOP, GLP/GDP/GMP & Safety Procedure. 19.Preparation of working standards. 20.Participate in cleaning validation and analytical method validation/ verification. 21.Review Instrument qualification report of IQ/OQ/PQ. 22.Perform Calibration of HPLC /UPLC instrument.