1.To perform line clearance in NOSD manufacturing facility.

2.To perform In-process checks during manufacturing, filling operation and sampling for any study as applicable.

3.To perform In-process (Bulk) & finish product sampling, rinse water sampling, any other sampling and management of samples through LIMS and SAP HANA as applicable.

4.To actively participate in the media fill simulation, review of the media fills protocol and summary report.

5.To perform assessment of breakdown of manufacturing machines/systems as per requirement.

6.To prepare/review of process records, review of SOPs, drafted records Qualification documents and other relevant GMP documents.

7.Operation and review of NVPC Instrument and relevant documents.

8.Handling of activities in SAP HANA as applicable.

9.Preparation and Execution of Process Validation, cleaning validation and Media fill Protocol & Reports.

10.Compilation of Annual Product Quality Review (APQR).

11.To perform/participate in investigations as per requirement.

12.To ensure GMP compliance of NOSD manufacturing facility.

13.Initiate/prepare and review of SOPs, Change control, Deviations as applicable in EDMS/Track wise.

14.Ensure completion of all applicable/assigned trainings in LMS/applicable methods.

15.To review and perform Audit trial of different equipments and Instruments as per plan.

16.To perform creation and deactivation activity in Medhas.

17.To prepare and review the Cleaning Validation Protocols and reports.

18.Handling of activities in EADMS as applicable.

19.To initiate and perform investigation of any reported discrepancy in Track-wise.

20.Evaluation and approval of change control in Track-wise.

21.SOP revision and recent SOP implementation in EDMS.

22.Batch release (SFG & FG) in SAP HANA.

23.To impart training as Qualified trainer.





24.Any other work assigned by Reporting Manager and Department Head.

Secondary Responsibility:

1.0 To Execute, monitor review and approval of Quality management system i.e. Change control, Deviation and CAPA management as per requirement.

2.0To Review and approve standard operation procedure.

3.0To ensure the compliance of document at various stages of the process i.e. (Manufacturing, Filtration, Filling and other packing operations).

4.0To review and approve the master and executed BMR, BPR, Validation, Qualification and other GMP documents.

5.0To evaluate and monitor the Aseptic process simulation (Media fill) activities with respect to the APS planner.

6.0To review update to GQS /regulatory audit observation with the stipulate time frame.

7.0To participate in the review and approval of investigation in case of Non-conformance events i.e. process deviation, OOS, OOT and Product quality complaint.

8.0To ensure release, approval of rejection of RM, PM, Intermediate, FP as per approved specification.

9.0To ensure compliance and implementation CAPA as per established procedure and follow up to verify the effectiveness of CAPA.

10.0 To ensure the complies of electronic system such as manufacturing equipment /Instrument etc.

11.0To ensure equipment /instrument, Qualification /Calibration and PM are performed as per approved planner.

12.0To ensure the processing and storage area qualified as per the approved procedure and GMP requirement.

13.0To ensure and perform work as per established approved procedure regulatory norms and its compliance as per the current regulatory requirements.

14.0To be part of internal external quality audit pertaining to NOSD.

15.0To handle product recall as per the approved procedure as applicable.

16.0Performed any other responsibility assigned by the Quality head /Management

Interested candidates can send resumes to [email protected]

📌 Parenteral IPQA Manager (Guwahati)
🏢 SUN PHARMA
📍 Guwahati