1. To interact with IPQA associates, to guide about new techniques about ensuring and reviewing of compliance level, provide awareness about QMS, assigning the specific job to different associates on daily/need basis.
2. To ensure that associates are performing the checks during production to monitor and if applicable to adjust the process and/or that intermediates or finished goods are conforming to its specification.
3. To review and ensure that associates are randomly cross verifying the yield verification of Intermediates and APIs reported by production associates.
4. To review and ensure that In-process sampling is being performed in manufacturing blocks in-line with written and approved procedures mentioned in Batch Production and Batch Cleaning Records.
5. To ensure that line clearance to manufacturing blocks is provided by IPQA associates only after verification of related documents, surrounding areas of equipment for cleanliness and compliance in related controls.
6. To review and ensure GMP compliance in production blocks, warehouse, engineering, quality control, quality assurance and other departments wherever GxP activities are being performed.
7. To review and ensure that the monitoring of sampling activities during intermediates and finished goods by Quality Control / IPQA associates being performed.
8. To ensure that sampled containers (finished products, dispatch able intermediates and other intermediates) are sealed immediately after sampling.
9. To ensure that BPRs & BCRs and related logs are being filled by shop floor personnel at production blocks, contemporaneously and IPQA associates are randomly reviewing on-line documentation with respect to completeness, accuracy and adequacy.
10. To review and ensure the adherence to preventive maintenance schedule and proper documentation related to maintenance activities.
11. To ensure that the weighing balances are being calibrated as per schedule and maintained in the state of compliance.
12. To review and ensure that the on-line monitoring of various activities by IPQA associates with respect to calibration of gauges, instruments and indicators is carried out as per schedule and ensuring the availability of calibration tags near to respective instruments and all tags are within the state of calibration.
13. To ensure that major observations (if any) with respect to GMP/GDP in production blocks, warehouse, engineering department and all other department wherever GxP activities are being highlighted to the Site QA Head & Plant Head and Deviation is raised by concerned department.
14. To participate in Validation programs and execution of VMP.
15. To conduct Internal Audits, QMS Audits, Quality Audits along with Corporate Quality Assurance and External Audits as per schedule.
16. To review and approve documents like SOPs, Specification and test methods, Formats, Master BPRs/BCRs, Protocols and Reports etc.
17. To participate in Designing, Development and Implementation of controlled documentation system in Production, Warehouse and Engineering departments.
18. To review, approve/reject proposed reprocess/rework procedures, Change Controls, Deviations, Investigations and CAPAs etc.
19. To participate and coordinate in responding to deficiencies received from regulatory authorities regarding DMFs.
20. To review, approve Annual Review Reports of site products (wherever required) and the campaign reports, prepared by production or Process Engineering team.
21. To participate and conduct Scheduled on the Job (SOJT), Unscheduled on the Job (UOJT) and Scheduled Good Manufacturing Practices (SGMP) Training.
22. To extend support to other units of Sai for maintaining and ensuring compliance with respect to good manufacturing / good documentation /warehouse and engineering practices.
23. To participate and Handle Regulatory and Client Audits/Visits being held at all units of Sai (as per requirement).
24. To impart induction training to new joiners to spread awareness about quality culture at Sai, expectation from the all the employees joining Sai, to motivate specially experienced persons to share their experience and knowledge. Also to take feedback of outgoing employees to know about the experience, learning and implementation of new procedures to improve the level of compliance.
25. To perform the any additional duties/responsibilities assigned by HOD or Site QA Head.
