Name : Isha Naik

BU : Quality Assurance

Place : ZLL-SEZ Oncology Injectable, SEZ, Matoda, Ahmedabad.

Email Id : [email protected]

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 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

Mail your CVs to: [email protected]

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