ASSOCIATE

Department Details

Role Summary

Ensure adherence to cGMP requirements. • Ensure adherence to EHS compliance at Quality Control Analytical laboratory. • Follow Good Documentation Practices (GDP) as per ALCOA principles for recording QC work/ activities. • Ensure proper safe and regular disposal of laboratory waste such as solvent, reagents, remaining sample, etc. following the requirements of EHS department and per local regulations. • Strictly adhere to use required PPE in laboratory during solvent dispensing or sample analysis. • Ensure the laboratory facilities and equipment(s) maintained as per established procedure. • Ensure the laboratory consumables (micropipettes, volumetric glassware, chemicals, etc.) are maintained as per established procedures • Perform calibration/verification on equipment's/ Instruments of Analytical balances, pH meters, HPLC, GC, AAS, UV Spectro meter, IR, Melting point apparatus, KF titrator, Refractometer, TOC analyser and record log entry in respective usage logbook of equipment/instrument in QCA Laboratory. • Assist in drafting/revision and continuous improvement of all relevant SOPs, EOPs, Specifications-Standard Test Procedure in accordance to cGMP/ pharmacopoeia requirement. Initiate change control, as necessary. • To perform any other task and work activity as assigned. • Preparation of Calibration / Preventive maintenance schedules • Co-ordinating with the vendor for scheduling the PM visits / Breakdown calls • Renewal of AMC / CMC contract with the OEM or Service providers of all the laboratory instruments • Procurement / Maintenance of Spares / Consumables for the laboratory instruments • To perform any other task and work activity as assigned.

Key Responsibilities

Ensure adherence to cGMP requirements. • Ensure adherence to EHS compliance at Quality Control Analytical laboratory. • Follow Good Documentation Practices (GDP) as per ALCOA principles for recording QC work/ activities. • Ensure proper safe and regular disposal of laboratory waste such as solvent, reagents, remaining sample, etc. following the requirements of EHS department and per local regulations. • Strictly adhere to use required PPE in laboratory during solvent dispensing or sample analysis. • Ensure the laboratory facilities and equipment(s) maintained as per established procedure. • Ensure the laboratory consumables (micropipettes, volumetric glassware, chemicals, etc.) are maintained as per established procedures • Perform calibration/verification on equipment's/ Instruments of Analytical balances, pH meters, HPLC, GC, AAS, UV Spectro meter, IR, Melting point apparatus, KF titrator, Refractometer, TOC analyser and record log entry in respective usage logbook of equipment/instrument in QCA Laboratory. • Assist in drafting/revision and continuous improvement of all relevant SOPs, EOPs, Specifications-Standard Test Procedure in accordance to cGMP/ pharmacopoeia requirement. Initiate change control, as necessary. • To perform any other task and work activity as assigned. • Preparation of Calibration / Preventive maintenance schedules • Co-ordinating with the vendor for scheduling the PM visits / Breakdown calls • Renewal of AMC / CMC contract with the OEM or Service providers of all the laboratory instruments • Procurement / Maintenance of Spares / Consumables for the laboratory instruments • To perform any other task and work activity as assigned.

Educational Qualifications

Required Education Qualification: B.Sc
Required Experience: 2 - 4 years