Senior Executive,Exexutive

1. Following GMP, safety practices in production facilities and work place.

2. Responsible for production activities as Shift-in-charge:

• Preparation of shift schedule.
• Execution of area, line clearance before execution of activities.
• Execution of product changeover activities.
• Ensuring material arrangement before activities.
• Execution of production activities.
• Updation and review of batch parameters.
• Verification of samples for analysis.
• Responsible for shift handover.
• Execution of process validation.
• Execution of cleaning validation.
• Review of batch monitoring and performance.

3. Handling of documents:

• Preparation / revision of SOPs, protocols and reports.
• Preparation of MFR’s and BMR's.
• Primary review of executed BMR's, submission to QA.
• Updation, review of log books (Seed room, bioreactor room).

4. Responsible for Quality Management Systems

• Initiation of breakdown request.
• Initiation of CRN's.

5. Responsible for operation of following production equipments (but not limited to):

• 200 L SS bioreactors

• pH meter

• 20/50 L cultibags

• Peristaltic pumps

• Biosafety cabinets

• Filter integrity tester

• Waterbath

• Depth filtration holder

• Cold cabinet

• Turbidimeter

• Microscope

• CO2 shaker incubator

• 1000 L Single Use bioreactor (SUB)

• 200 L Single Use bioreactor (SUB)
• Monitoring during data backup of equipments.
• Provide clearance for calibration, PMP and validation of equipments.
• Participate in execution of equipment validations.

6. Team member:

• Facility readiness for audits / self-inspection.
• Safety committee.

7. Training:

• Training team members on SOP’s / GMP aspects.
• Attending training on related SOP's / GMP aspects.

8. Responsible for equipments: (SOP/log book/Validation/PMP etc)

• 200 L SS bioreactors

Peristaltic pumps