ipqa / qms

Name: Isha Naik
BU: Quality
Place: ZLL-SEZ Oncology Injectable, SEZ, Matoda, Ahmedabad.
Contact:
Email Id:

• Position:
• Designation: Associate Manager/Deputy Manager
• Reports to: QA Head
• Department: Quality Assurance
• Location: ZLL-SEZ Oncology Injectable (Alidac)
• No of Posts: 1
• Role: Critical
• Neev Level: 2
• Details: Replacement
• Position Code:
• Position Name: IPQA / QMS

• To ensure shop floor compliance with cGMP and GDP and facility/equipment upkeeping.
• To ensure sampling as per defined frequency and methodology during batch manufacturing of all validation activities and exhibit batch manufacturing.
• To review executed batch records and to release the batch along with necessary entries in SAP.
• Responsible for stage-wise review of electronic data parameters, review by exception, and sign in MES wherever applicable.
• To ensure the gowns used in the area are defect free and to ensure that gowning procedure is followed respective area-wise entry/exit SOP.
• To interact with Production on the non-conformance (if any) and discuss the corrective actions.
• To support qualification of Vial washing, tunnel, filling, CIP/SIP liquid and powder, capping, ALUS, Glove integrity tester, external vial washing, Isolator, HVAC, General production area and validation of equipment/instrument and machine along with their documentation.
• To ensure shop floor compliance of operational activities in filling line (Vial washing, tunnel, filling, CIP/SIP liquid and powder, capping, ALUS, Glove integrity tester, external vial washing area, Isolator and HVAC).
• To support the investigation of the deviation/incidences, non-conformances, market complaints, and OOS (Phase II- Process Investigation) and to verify the CAPA proposed in the area of operation.

• To carry out failure investigation in exhibit/engineering and PPQ batches.
• To review and approval of the failure investigation report.
• To review and approve PPQ protocol and report to verify the executed data and review the summary report.
• To check the summary reports prepared post-completion of the process validations issues.
• To review the data of the exhibit batch, engineering batch, and PV batches, and to ensure that learning of CQA, CMA, and CPP gets transferred to subsequent stages.

1. Handling of quality management system (QMS) i.e. Change control, deviation, CAPA and risk assessment of production department as per respective SOPs.
2. To evaluate the proposed change and its impact or risk associated with safety, purity, efficacy, and quality of the product, cGMP system, documentation, regulatory impact, and training requirement.
3. To identify concerned departments from where evaluation/information of change is required like Regulatory Affairs, GDSO, F&D/R&D, PTC, ADL, Marketing, Manufacturing Science & Technology (MS&T), Technology Services, Central Quality, or any other functions as applicable and forward to the initiator to get approval from these concerned departments for their evaluation/comments and acceptance/information.
4. To constitute a cross-functional team (reviewer board) based on the change proposed (such as Production, QA, QC, Site Head, validation QA, regulatory affairs, engineering, GDSO, R&D/PTC/MS&T, warehouse, or additional reviewer as applicable).
5. To monitor the implementation of the approved change once the proposed change is approved by Head QA.
6. To log the deviation, investigation, OOS, and OOT in Trackwise/in the applicable system.
7. To request further information/data supporting the Deviation, Investigation, OOS, and OOT.
8. Responsible for review of adequacy, quality, and completeness of all other QMS documents investigation.
9. Responsible for identification of repetitive nature of issues, history linking of investigations for product process and personnel by collecting associated and available evidence.
10. Responsible for initiating/following up on corrective and preventative actions and reviewing and approving quality critical changes.

• Qualification: M. Pharm/B. Pharm
• Years of Experience: 10 to 15 Years
• Experience in Zydus: 03 Years
• Experience/Exposure in: Must have knowledge and experience in injectable plant.

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Locations: Manufacturing-formulation | , Ahmedabad, Gujarat, India