Trainee QA

3 days ago


Ahmedabad Gujarat, India Zydus Group Full time

Department
- VTC MFG. QA
- Job posted on
- Sep 18, 2024
- Employment type
- T-T6-Trainee-R&D Executive

**1.**

To ensure shop floor compliance to CGMP and GDP and facility/equipment up keeping at Inactivated Virus Vaccine plant (IVP), Fill Finish Virus Vaccine Plant (FFV)

**2.**

To provide oversight observation for GMP Compliance at Inactivated Virus Vaccine plant (IVP), Fill Finish Virus Vaccine Plant (FFV).

**3.**

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

**4.**

To ensure status labelling of area, equipment, instrument for any non -compliance, segregation of the materials as per desired storage conditions.

**5.**

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

**6.**

To ensure sampling as per defined frequency and methodology during batch manufacturing of all validation activities and exhibit batch manufacturing and do the entry of the samples in LIMS software.

**7.**

To review executed batch manufacturing and batch packing record of in Inactivated Virus Vaccine plant (IVP), Fill Finish Virus Vaccine Plant (FFV).for accuracy, completeness and compliance.

**8.**

To verify the calibration and cleaning of manufacturing equipment.

**9.**

To prepare SOP related to QA-Operation in D2 (Documentum) and ensure its compliance.

**10.**

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 contemptuous documentation.


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