Parenteral IPQA Manager

Sun Pharma; Kamrup Metropolitan; On-site; INR 550,000 - 900,000; Full time

Job summary

Sun Pharma in NOSD facility is seeking a QA professional to ensure GMP compliance, execute line clearance, in-process checks, sampling, and change control activities across manufacturing and packaging.

The role involves auditing, documentation reviews, training, CAPA closure, and collaboration with SAP HANA/LIMS systems, with emphasis on media fills, APQR, and investigations.

Responsibilities

• Perform line clearance in NOSD manufacturing facility.
• Conduct in-process checks during manufacturing, filling, and sampling as required.
• Perform in-process (bulk) and finish product sampling, rinse water sampling, and manage samples via LIMS and SAP HANA.
• Participate in media fill simulations and review media fills protocol and summary reports.
• Assess breakdown of manufacturing machines/systems as required.
• Prepare/review process records, SOPs, drafted records Qualification documents and other GMP documents.
• Operation and review of NVPC Instrument and relevant documents.
• Handle activities in SAP HANA as applicable.
• Prepare and execute Process Validation, cleaning validation and Media fill Protocol & Reports.
• Compile Annual Product Quality Review (APQR).
• Participate in investigations as per requirement.
• Ensure GMP compliance of NOSD manufacturing facility.
• Initiate/prepare and review SOPs, Change control, Deviations as applicable in EDMS/TrackWise.
• Ensure completion of all trainings in LMS/applicable methods.
• Review and perform Audit trail of different equipments and Instruments as per plan.
• Perform creation and deactivation activity in Medhas.
• Prepare and review the Cleaning Validation Protocols and reports.
• Handling of activities in EADMS as applicable.
• Initiate and perform investigation of any reported discrepancy in Track-wise.
• Evaluation and approval of change control in Track-wise.
• SOP revision and new SOP implementation in EDMS.
• Batch release (SFG & FG) in SAP HANA.
• Impart training as Qualified trainer.
• Any other work assigned by Reporting Manager and Department Head.

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, 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 new 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