Role name: QC - QMS - GLP
- Department - Quality Control
- Qualification - M.Sc./B.Pharma/M.Pharma
Zydus Experience - Must have completed at least two PMS cycle.
Job Responsibilities:
Main activities- related to Trackwise - Change control/ CAPA /NQ incident trend / Risk assessment (rarely) / IRA documents submission like, raw data/chromatogram etc. , Effective ness check of CAPA in track wise / SOP revision and Training)
1. To ensure day-to-day monitoring and compliance of the laboratory activities.
2. To ensure data integrity and good laboratory practices in the department.
3. To ensure global CAPA implementation within timeframe. / To comply the statutory compliance aspect.
4. To follow the Good Laboratory Practices.
5. To maintain interpersonal relationship and provide support to other functional group in the department.
6. To maintain data integrity and follow cGMP and GDP.
7. To ensure that training is acquired for each activity/instrument prior to its execution/operation and that it is as per respective TNI.
8. To maintain and ensure controlled laboratory practice in the quality control department.
9. To ensure laboratory inventory management.
10. To follow the SOPs of Quality control department and related area.
11. To prepare / revise the SOP's, related to QC in software except microbiology lab.
12. To impart the training after revision of SOPs as per the requirement.
13. To perform related documentation/transaction in the software (e.g. LIMS, Zytims/Trackwise/SAP) based on assigned user privileges.
14. To assist in the Qualification / Installation of instrument equipment with suitable documentation.
15. To perform the qualification of instruments as per the requirements
16.To co-ordinate with in-house service engineers and / or external service engineers as and when required.
17. To participate and provide appropriate feedback during failure investigation (if any).
18. To review the raw data of Raw material / Finish product /stability sample/ Validation sample / Exhibit sample analysis with respect to SOP and GDP.
19.To ensure the destruction of remainant samples after analysis as per applicable procedure.
20. To ensure the usage of required PPE’s during respective activities in the laboratory.
21.To ensure up-keeping of the instrument/equipment.
22.To inform section head about any OOS/ OOC/Incident on its immediate occurrence and for day to day activities.
23.To investigate OOS/OOC/Incident (if any) under consultation with the department head/section head.
24.To keep the things and work area clean and tidy and get involved for the routine trouble shooting (if any).
25. To execute the activities with maximum output with complete documentation.
26. To provide documentation of commercial batches to IRA.
27. Responsible for implementing company quality ethics policy for data integrity and inform management and responsible data integrity compliance head on any data integrity issues as per corporate data governance policy.
28. To prepare the audit response of internal/external customer/SME observation to QC.
29. To perform related documentation/transaction in the software (e.g. LIMS, SAP, Trackwise, DMS, Minitab, Zytims, Legatrix) based on assigned user privilege.
30. To initiate, track and closure of QMS event (CAPA, change control, incident, deviation, event, extensions etc, through Trackwise and in format-based system) and escalate it for completion.
31. Handling of laboratory information Management System (LIMS) system under the guidance of LIMS administrator, which includes preparation/modification/review and approval of specifications, worksheets, tests plans, stability protocols, Masters etc. as per requirement.
32. To assist Validation/Re-validation of LIMS modules as and when required.
33. To prepare validation protocol and report and co-ordinate for the validation of spread sheets as and when required.
34. Completion of Any other specific work or assignment as given by the section head/department head.
35. To report abnormalities (if any) to section head or designee.
33. To prepare Quality metrics and QI sheet, department level QRM data and to record action plan
34. To prepare trend data of QMS events.
35. To prepare analytical method verification/validation protocol/report.
36. To initiate the activity regarding New / revision of technical agreement / Quality agreement.
37. To initiate the Risk assessment / Gap assessment involving in the respective activity
38. To Make entry and verify the details in Zytimes.
39. To perform the required activities related to QUEST / SLIM programme.
40. To perform the required activities related to statutory requirements in Legatrix.
41. Management of column and other resources used in analytical activities.
42. To escalate the Issues related to the Process, Product, Quality, Cleaning process or documentation related activities to his/her immediate supervisor and take the appropriate action related to it.
43. To escalate any failures and overdue activity that can have a potential impact on product quality to his/her immediate reporting authority.
