QA SME

5 days ago

Ahmedabad, India ZYDUS LIFESCIENCES LTD Full time

Org Structure

ZHL DAMAN PLANT QA

Job posted on

Sep 15, 2025

Employee Type

C-C7-Confirmed-HO Staff

Experience range (Years)

2 years - 5 years

Sr. No.

Job Responsibility

01

Instrument Calibration Planning considering due date, communicate with External Party, Calibrated the Instruments which are installed in Area.

02

Responsible for conducting and planning of Area Validation considering due date, correspondence with External Party, perform the Test as Air Velocity, PAO Test, Particle Count, Air Flow and Temperature Mapping.

03

Balance Calibration Planning considering Due Date, inform to External Party, Calibrate the Balance which is available in Area. Monthly Calibrate the IPQC Instrument as per due date and fill-up the Formats.

04

After Calibration and Validation Activity, Reviewing and compilation Reports.

05

Preparation and Verification of Qualification Protocol for new Equipment.

06

Preparation of new SOP related Validation.

07

Preparation of IQ, OQ & PQ protocol, execution of activity and preparation of its Report.

08

HVAC Validation for newly installed System, perform the IQ, OQ & PQ and preparation of its Report.

09

Vial Washing Machine, Depyrogenation Tunnel and Autoclave Qualification.

10

Media Fill Protocol Preparation, Execution and Review of its BMR & Video Recording.

11

Process Gas Qualification.

12

Handling, Evaluation & Investigation of Deviation Control and Change Control.

13

To give Area Line Clearance at various stages of manufacturing and Packing by verifying checkpoints as per respective area checklist in Injection Department.

14

Verify the Process Validation up to its completion of three batches of new product and BMR finalization.

15

To perform in process of various Stages of Manufacturing and Packing.

16

To perform Sampling as per Sampling plan at various stages of Manufacturing and Packing.

17

To perform Environmental Monitoring in Manufacturing Area.

18

Coordinating in CAPA & Market Complaint activity.

19

Responsible for Control Sample Management Activity.

20

Responsible for Stability Management activity of QA in QC.

21

  1. Review of departmental SOP's for verification of adequacy of the defined procedure and ensure compliance.

22

Responsible for quality oversight of personnel, process and practice to meet the cGMP and compliance requirement. To verify the system & identify the gaps for improvement.

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