IPQA Sterile

Zydus Group; Ahmedabad District; On-site; INR 700,000 - 1,000,000; Full time

Job summary

Zydus Lifesciences is seeking a Senior Executive in Quality Assurance for the SEZ Oncology Injectable unit in Ahmedabad, Gujarat. The role focuses on ensuring cGMP/GDP compliance on the shop floor and maintaining equipment readiness. You will review IPQA checks, aseptic practices, and SOPs, and participate in BMR/BPR reviews and batch release in SAP/MES.

Candidate should have 6–10 years of QA experience in pharma manufacturing and hold B. Pharma/M.Pharm/M.Sc. Microbiology.

Qualifications

• 6 to 10 years of experience in QA for pharma manufacturing.

Responsibilities

• Ensure shop floor compliance with cGMP and GDP and keep facility/equipment upkeeping.
• Ensure defined IPQA checks are followed and documented during manufacturing and packing.
• Review and ensure aseptic practices.
• Prepare and review QA SOPs and other departmental SOPs.
• Review Drug Product BMR/BPR and aseptic process simulation BMR before execution.
• Review executed batch records and release batch with required SAP entries.
• Review process validation, cleaning validation and aseptic process simulation study protocols and reports.

Education

B. Pharma /M. Pharma/M.Sc. Microbiology

Job description

Manufacturing-formulation|SEZ - ONCOLOGY, Ahmadabad, Gujarat, India

6 - 10 Years

Job Description

BU : Quality Assurance

Basic Details:

Position : 60062953

Designation : Senior Executive

Department : Quality Assurance

Location : ZLL-SEZ Oncology Injectable (Alidac)

Noof Posts : 1

Role : SeniorExecutive

NeevLevel : 1

Details : Replacement

Positioncode : 60062953

Key Job Description:

Job Purpose

Toensure shop floor compliance with cGMP and GDP and facility/equipmentupkeeping.

To ensure thatdefined and approved IPQA checks are being followed,

documented duringmanufacturing and packing for compliance.

To review and ensurethe aseptic practices.

To prepare andreview QA SOPs and review of other departmental SOPs.

To review the Drugproduct BMR / BPR and Aseptic process simulation BMR before execution.

Toreview executed batch records and to release the batch along withnecessary entries in SAP.

To review of Processvalidation, Cleaning Validation and Aseptic process simulation study protocols,reports and video recording.

To perform thevisual inspector's qualification and documentation.

Toensure sampling as per defined frequency and methodology during batchmanufacturing of all validation activities and exhibit batchmanufacturing.

Responsiblefor stage-wise review of electronic data parameters, review by exception,and sign in MES wherever applicable.

Toensure the gowns used in the area are defect free and to ensure thatgowning procedure is followed respective area-wise entry/exit SOP.

Tointeract with Production on the non-conformance (if any) and discuss thecorrective 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 validationof equipment/ instrument and machine along with their documentation.

To ensure shop floor compliance of operationalactivities in filling line (Vial washing, tunnel, filling, CIP/SIP liquid andpowder, capping, ALUS, Glove integrity tester, external vial washing area,Isolator and HVAC).

Tosupport the investigation of the deviation/incidences, non-conformances,market complaints, and OOS (Phase II- Process Investigation) and to verifythe CAPA proposed in the area of operation.

Qualification : B. Pharma /M. Pharma/M.Sc. Microbiology

Yearsof Experience : 6 to 10 Years

Job Snapshot

Updated Date

23-10-2026

Job ID

JOB10543

Division

ALIDAC QA

Location

Location Manufacturing-formulation|SEZ - ONCOLOGY, Ahmadabad, Gujarat, India

At Zydus Lifesciences, w e nurture a culture of innovation, excellence, and inclusivity, driving meaningful advancement in the pharmaceutical and healthcare industries. Fueled by creativity, we constantly exploring new ways to improve patient care and expand healthcare accessibility.

Our commitment to a positive and empowering work environment has earned us recognition as one of India's Best Workplaces in Biotechnology & Pharmaceuticals.