Trainee

Job Description

Job Description Ensure the review & release of QC sample analysis, AnalyticalMethod validation, Cleaning Method Validation, Hold time sample, market complaintsrecord, instrument calibration records, Analyst qualification record andMiscellaneous study report. 2. Review of electronic data generated throughlaboratory instruments and review of executed analytical workbooks / Test Datasheet for In- process, Finished product, Stability, working standard,Analytical Method validation, Method transfer, Cleaning Method Validation, Holdtime sample, market complaints record, instrument calibration records, Analystqualification record and Miscellaneous study reports -- Suraj 3. Providedecision of acceptance / rejection of stability samples, Raw material,Packaging materials, instrument calibration lots, water sample lots &working standard records on the basis of analysis and ensuring entries intosystem. 4. Logging, evaluation and implementation of the incidents, deviations,change control & CAPA. 5. Investigation and root cause analysis requiredfor the critical incidents and failures. 6. Responsible to check the onlinedocumentation & ensure compliance to systems and procedures in QualityControl 7. Preparation and review of Standard Operating Procedures (SOPs) ofGlenmark Pharmaceuticals Limited. 8. Checking & approval of COA’s for Rawmaterial & Packaging materials. 9. Timely and effective communication andescalation of quality issues to the appropriate levels of management. 10.Issuance of log books / registers / formats to Quality control 11. Issuance ofFormats/TES in case of SAP shutdown. 12. Responsible to attend the trainingsessions as per schedule (TNI) or un-schedule training sessions. 13.Responsible to ensure the team members are trained by providing training onrelevant SOPs 14. Review of recent updation of the test methods as perPharmacopoeial / regulatory requirements. 15. LER & Extraneous peak Investigationreview & approval of LER. 16. Review of stability data compilation 17. ITApplications: Usage of QMS related T. Codes in SAP, Open Text, MS Office,Acrobat Reader, Departmental Drive, Skype, Outlook, GENESIS, HR Portal, ASPIRELearning Management System, Trackwise and Internet. 18. Maintain Environment,Health and Safety system as per ISO 14001:2015 & ISO 45001:2018. 19. Anyother responsibility assigned by Department Head.