Public Notice
*This job is PAUSED right now, but may get open in the future. You may present your information by applying.*
Job Objective:
Quality control is to test and verify the product quality in various stages such as Raw material, In-process, Finished product against the predefined standards & its documentation.
Key Responsibility:
1. To follow /implement quality policy, data integrity policy and EHS policy.
2. To follow good laboratory practices, good documentation practices, Good hygiene practices & good safety practices.
3. To allocate the work to subordinates as per the work priority.
4. To prepare /review specifications, method of analysis, analytical test data sheet.
5. To update the documents and impart trainings as per current pharmacopoeia/guidelines/regulatory requirements.
6. To review analytical data of API, intermediate, formulations, raw material, packing material & D /pilot plant batches, stability data, in process samples and ensure that analysis carried out as per approved specifications, method of analysis & SOPs.
7. To approve /reject API, intermediate, formulations, raw materials, packing materials, R & D, pilot plant batches, stability area, in process samples.
8. To update subordinate for the latest up-dation of guidelines and regulatory requirements.
9. To ensure that all QMS documents are updated and available as per requirement.
10. To ensure that all non-conformance/observations related to internal/external audits/inspections investigated and CAPA initiated and closed.
11. Investigating and resolving the critical deviations, laboratory incidence, OOT and OOS.
12. Investigating and resolving the quality related complaints of finished products.
13. Preparation and reviewing the standard operating procedure.
14. Review of training schedule and assessment of training.
15. To report seniors for any deviations or incidents occurred /noticed.
16. To initiate, review change control, incidence, deviations, OOS and OOT.
17. To ensure that investigation carried out for root cause investigation of deviations, OOS, OOT, & appropriate CAPA taken & implemented.
18. To ensure that references standards are available as requirement and to verify the status of current valid batch from relevant sources as per SOP.
19. To review the audit trail of all instruments in QC department to ensure any data integrity issue.
20. To review calibration schedule, record, history card, usage log book of instrument and ensure that all instruments are calibrated plan& maintain the records.
21. To ensure that the AMC of instrument are available and schedule for preventive maintenance followed.
22. To ensure that IT procedures implemented and followed.
23. To ensure that all related QA and other departments procedures implemented and personnel are trained.
24. To do trouble shooting related to analysis and instruments.
25. To initiate intends related to laboratory consumables, chemicals, reagents, glassware & other requirement and to ensure that inventory available as per requirement.
26. To do the method development as per requirement.
27. To follow up with external parties for smooth functioning of QC.
28. To coordinate with other departments for day to day planning.
29. Ensure effective functioning of QC laboratory.
30. Ensure the safety in QC laboratory.
31. To review/approval of analytical method validation protocol, reports.
32. To impart training on SOPs, GLP, QMS, GMP, & other as per requirement.
Basis.
Skills and Competencies required – (Display the following written skills and Behavioral competencies which are required for this position)
1) Confident, tact and a persuasive in nature.
2) Team working
3) Planning and organizing
4) Promoting core values of the organization
5) Ethical working
6) Eye for details
7) Sense of urgency and commitment to timelines and promises for work delivery
8) Ability to maintain required business secrecy
9) Provide leadership to team mates
Job Location : 1 Hour from Pune
