About this role
Handling and Monitoring of IPQA activities on shop floor.
? Principal Tasks:
1. In-process checking of manufacturing and packing.
2. Control Sample Management.
3. Review of documents/BMR/BPR at each stage of manufacturing and packing.
4. Handling & Monitoring of IPQA activity in packing area.
5. Calibration of IPQA instruments as per schedule.
6. Collection of sample for QC analysis, validation sample and other.
? Responsibilities:
1. Control sample receipt, entry in register, Sample management, Periodic review, Record of Control
Sample Withdrawal (intermittent) & Reconciliation. Environmental Monitoring of control sample
room. Periodic Destruction of Control samples.
2. Overall compliance w.r.t. documents data control.
3. Giving line clearance for all activities at shop floor.
4. In-process checking of manufacturing and packing.
5. In process sampling at different stages of manufacturing and packing.
6. Online review of batch manufacturing record and batch packing record.
7. Implementation and monitoring of all cGMP activities in manufacturing and packing area.
8. Monitoring of regular calibration on the production shop floor.
9. Any other job as and when assigned by In-charge–Quality Assurance.
? Environment and Health & safety:
IGC-SIDCO, PHASE-1, SAMBA (Ref. SOP No. HR021)
JOB DESCRIPTION
FORM No. HR021-01-04 Page No. 2 of 2
1. Responsible for ensuring compliance with EHS, GMP, and regulatory requirements by maintaining
personnel hygiene, clothing, and safe work practices.
2. Actively use PPE, uphold a clean and organized workplace, and participate in Environment, Health