About the role
Name : Isha Naik
BU : Quality Assurance
Place : ZLL-SEZ Oncology Injectable, SEZ, Matoda, Ahmedabad.
Basic Details:
Position : 60062953
Designation : Senior Executive
Reports to : Quality-Section Head
Department : Quality Assurance
Location : ZLL-SEZ Oncology Injectable (Alidac)
No of Posts : 1
Role : Senior Executive
Neev Level : 1
Details : Replacement
Position code : 60062953
Position Name :QA SME (Chemist)
Key Job Description:
Job Purpose
To ensure shop floor compliance with cGMP and GDP and facility/equipment upkeeping.
To ensure that defined and approved IPQA checks are being followed,
documented during manufacturing and packing for compliance.
To review and ensure the aseptic practices.
To prepare and review QA SOPs and review of other departmental SOPs.
To review the Drug product BMR / BPR and Aseptic process simulation BMR before execution.
To review executed batch records and to release the batch along with necessary entries in SAP.
To review of Process validation, Cleaning Validation and Aseptic process simulation study protocols, reports and video recording.
To perform the visual inspector's qualification and documentation.
To ensure sampling as per defined frequency and methodology during batch manufacturing of all validation activities and exhibit batch manufacturing.
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.Qualification : B. Pharma /M. Pharma/ M.Sc. Microbiology
Years of Experience : 6 to 10 Years