Sterile IPQA Senior Executive

Sun Pharma; Kamrup Metropolitan; On-site; INR 600,000 - 860,000; Full time

Job summary

Sun Pharma in Guwahati, Assam is seeking a GMP-compliant QA/Manufacturing professional to support NOSD facilities. Responsibilities include line clearance, in-process checks, sampling via LIMS/SAP HANA, media fill reviews, and APQR compilation, with emphasis on maintaining GMP compliance.

The role covers both NOSD manufacturing and packing facilities, with additional responsibilities in document review, SOP updates, change control, deviations, and training completions in LMS.

Responsibilities

• To perform line clearance in NOSD manufacturing facility
• To perform In-process checks during manufacturing, filling operation and sampling for any study as applicable.
• 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.
• To actively participate in the media fill simulation, review of the media fills protocol and summary report.
• To perform assessment of breakdown of manufacturing machines/systems as per requirement.
• To prepare/review of process records, review of SOPs, drafted records Qualification documents and other relevant GMP documents.
• Operation and review of NVPC Instrument and relevant documents.
• Handling of activities in SAP HANA as applicable.
• Preparation and Execution of Process Validation Protocol & Reports.
• Compilation of Annual Product Quality Review (APQR).
• To perform/participate in investigations as per requirement.
• To ensure GMP compliance of NOSD manufacturing facility.
• Prepare and review of SOPs, Change control, Deviations.
• Ensure completion of all applicable/assigned trainings in LMS/applicable methods.
• To perform Cleaning Validation sampling and review the Cleaning Validation Protocols.
• To review and perform audit trail of different equipments and instruments as per plan.
• Secondary Responsibility:
• To perform line clearance in NOSD Packing facility.
• To perform sampling of control, stability, any other sampling and management of sample through LIMS.
• To perform AQL of visually inspected & packed goods.
• To review of new/revised/executed BPRs.
• To review of process records, review of SOPs, and other relevant documents.
• To perform line clearance in NOSD warehouse for RM sampling, Raw and packing material dispensing.
• To check and ensure online rejection, rejection of received defective material, storage of cold chain materials, quality checks sampling.
• To ensure the calibration / verification of weighing balance, calibration of weight etc.
• Preparation and Execution of Process Validation Protocol & Reports.
• To ensure the GMP compliance of NOSD packing facility, warehouse facility.
• Initiate/prepare and review of SOPs, Change control, Deviations as applicable in EDMS/Trackwise.
• Ensure completion of all applicable/assigned trainings in LMS/applicable methods.
• To perform activities of Department Training Co-ordinator in LMS.
• To check the audit trails of manufacturing and packing systems as applicable.
• To ensure the GMP compliance of Parenteral packing and Parenteral ware house facility.
• To perform line clearance in Parenteral packing and Parenteral ware house facility.
• To perform In-process checks during packing operation and sampling for any study as applicable.
• To perform In-process & finished product sampling and management of sample through LIMS 5.0
• To perform AQL of visually inspected and packed goods.
• To prepare/review of SOPs/Protocols and other GMP documents as applicable.
• Review of new/revised/ executed BPRs.
• To check / Review of the log books related to Parenteral Packing and Parenteral Ware House.
• To perform assessment of breakdown of packing machines / systems as per requirement.
• To perform GAP Analysis.
• To prepare and review of Annual Product Review.
• To prepare and review of risk assessment pertaining to Packing.
• Job Location: Palasbari, Mirza, Guwahati, Assam

Tools

NOSD GMP systems

Job description

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 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.Prepare and review of SOPs, Change control, Deviations.

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

15.To perform Cleaning Validation sampling and review the Cleaning Validation Protocols.

16.To review and perform audit trail of different equipments and instruments as per plan.

Secondary Responsibility:

1.To perform line clearance in NOSD Packing facility.

2.To perform sampling of control, stability, any other sampling and management of sample through LIMS.

3.To perform AQL of visually inspected & packed goods.

4.To review of new/revised/executed BPRs.

5.To review of process records, review of SOPs, and other relevant documents.

6.To perform line clearance in NOSD warehouse for RM sampling, Raw and packing material dispensing.

7.To check and ensure online rejection, rejection of received defective material, storage of cold chain materials, quality checks sampling.

8.To ensure the calibration / verification of weighing balance, calibration of weight etc.

9.Preparation and Execution of Process Validation Protocol & Reports.

10.To ensure the GMP compliance of NOSD packing facility, warehouse facility.

11.Initiate/prepare and review of SOPs, Change control, Deviations as applicable in EDMS/Trackwise.

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

13.To perform activities of Department Training Co-ordinator in LMS.

14.To check the audit trails of manufacturing and packing systems as applicable.

15.To ensure the GMP compliance of Parenteral packing and Parenteral ware house facility.

16.To perform line clearance in Parenteral packing and Parenteral ware house facility.

17.To perform In-process checks during packing operation and sampling for any study as applicable.

18.To perform In-process & finished product sampling and management of sample through LIMS 5.0

19.To perform AQL of visually inspected and packed goods.

20.To prepare/review of SOPs/Protocols and other GMP documents as applicable.

21.Review of new/revised/ executed BPRs.

22.To check / Review of the log books related to Parenteral Packing and Parenteral Ware House.

23.To perform assessment of breakdown of packing machines / systems as per requirement.

24.To perform GAP Analysis.

25.To prepare and review of Annual Product Review.

26.To prepare and review of risk assessment pertaining to Packing.

Job Location: Palasbari, Mirza, Guwahati, Assam