IPQA Sterile

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

Responsibilities

• 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.

Requirements

• B. Pharma /M. Pharma/.

Microbiology Years of Experience

6 to 10 Years Mail your CVs to: