ZTMP-IPQA

ZTMP – REQUEST FORMAT

Name : Neha

BU : Tech-ops (Formulations)

Place : Zydus Lifesciences Ltd., Baddi, H.P

Contact # : 7807888605

Email Id : Neha.Thakur@zuduslife.com

Basic Details:

Position : IPQA

Designation : Executive/Sr Executive

Reports to : Section In charge

Department : Quality Assurance

Location : Zydus Lifesciences Ltd., Baddi, H.P

No of Posts : 01

Role : Critical

Neev Level : Level 1

Details : Replacement

Position Name : Executive-QA

Key Job Description:

In process Checks

1. To ensure shop floor compliance to cGMP and GDP and facility/equipment up keeping.

2. Responsible daily oversight of document destruction process.

3. Responsible for quality oversight of personnel, process and practice to meet the cGMP and compliance requirement.

4. To ensure status labelling, segregation of the materials as per desired storage conditions.

5. Responsible for implementing company quality ethics policy for data integrity and inform management and responsible data integrity compliance head on any data integrity issues as per corporate data governance policy.

6. To provide line/equipment clearance prior to manufacturing, and packaging and validation activity during Batch and Product change over.

7. To check the gowns used in the area are defect free and to ensure that gowning procedure is followed respective area wise entry/exit SOP.

8.To interact with Production on the non-conformance (if any) and discuss the corrective actions.

9. To evaluate and comment on change proposals initiated in the area of operation.

10.To perform in process checks during batch manufacturing and packing as recommended in batch record/ SOP.

11. Any other work assigned by department Head.

Sampling

1) To ensure sampling as per defined frequency and methodology during batch manufacturing of all validation activities, routine commercial batches and exhibit batch manufacturing.

2) To ensure submission of the samples to QC for analysis. To ensure the batch detail in LIMS and submission of samples to QC for analysis along with sampling sheet.

3. Swab and Rinse sampling for cleaning validation as mentioned in Protocol / SOP.

4. Sampling of Purified Water as per SOP.

5. Responsible for implementing company Quality Ethics policy for data integrity and inform management and responsible Data integrity compliance head on any data integrity issues as per corporate Data governance policy.

6. Any other work assigned by department Head.

Calibration

1) To verify the calibration and cleaning of manufacturing equipment.

2) Responsible for calibration / verification of various IPQA apparatus like Balance, Disintegration test Apparatus, Hardness Tester, Friability test apparatus, Halogen Moisture Analyzer, Torque tester etc.

3) Responsible for implementing company Quality Ethics policy for data integrity and inform management and responsible Data integrity compliance head on any data integrity issues as per corporate Data governance policy.

4) Any other work assigned by department Head.

Documents Review

"1) To review executed batch records and to release the batch along with necessary entries in SAP.

2) Responsible for stage wise review of electronic data parameters, review by exception and sign in to software wherever applicable.

3) To review SOP related to manufacturing area and ensure compliance.

4) To review respective manufacturing log books (for e.g., area cleaning logbook, equipment usage logbook) and environmental monitoring records (for e.g., temperature and humidity logbook) and to ensure contemporaneous documentation.

5) To review electronic records like PLC, SCADA, equipment printouts, audit trails, alarms and events as per site SOP.

6) To review formats used for recording of parameters during operation in case of any change/ alter/ modification in the PLC/HMI/MMI and audit trails print out at the time of Batch release for transfer to packing or release for dispatch.

7) To perform random checking desktop policy and to ensure housekeeping of system and area.

8) To review and approve impact assessment of change in parameters.

9) To support investigation of the deviation/incidences, non-conformances, market complaint, OOS (Phase II- Process Investigation) and to verify the CAPA proposed in the area of operation.

10) Responsible for implementing company Quality Ethics policy for data integrity and inform management and responsible Data integrity compliance head on any data integrity issues as per corporate Data governance policy.

11) Any other work assigned by department Head.

Trending

1. To prepare and review GDP error trend as per the SOP on Good Documentation practices

2. To prepare and trend Line Clearance failures (if any) as per the SOP on Line Clearance

3. On line trending of Critical process parameters for every manufactured batch.

4.Responsible for implementing company Quality Ethics policy for data integrity and inform management and responsible Data integrity compliance head on any data integrity issues as per corporate Data governance policy.

Batch Release

1.To release the batches for market distribution as per the Standard operating procedure after review of Batch records, Certificate of analysis, Critical process parameters and Critical quality attributes.

2.Responsible for implementing company Quality Ethics policy for data

integrity and inform management and responsible Data integrity compliance

head on any data integrity issues as per corporate Data governance

policy.

Requirements:

Qualification : B. Pharma/M. Pharma/MSc

Total Years of Experience : 6-12 Years

Experience in Zydus : Min. Two Year

Experience / Exposure in: Knowledge of Quality Assurance .

From which Dept. people can apply: QA /IPQA/Having Similar Work.

Mail your CVs to: Neha.Thakur@zuduslife.com

Job Snapshot

Updated Date

10-09-2026

Job ID

JOB10941

Division

BADDI QA

Location

Manufacturing-formulation|for .mfg. Baddi, Baddi, Himachal Pradesh, India

Experience

6 - 12 Years

Employee Type

P-P8-Probationer-HO Executive