Purpose-To ensure shopfloor compliance as per the GMP norms and ensure on time delivery of the products.
Position / Job Title-Officer
Department-Quality Assurance: In-Process Quality Assurance
Reporting To-Sr. Manager, Quality Assurance
Location-Pithampur
Years of Experience-4-7 Years
Dosage Form-Solid Oral/ Cream/ Ointment
Job Responsibilities / Deliverables
- To review change control and assign tasks to the respective stakeholders as per change control and ensure closure of task on time.
- Ensure closure of change control on time.
- To review corrective and preventive action and track for closure.
- To review and participate in the investigations and ensure on time closure.
- To investigate market complaints and ensure closure on time.
- To prepare summary reports of change control, CAPA, deviation and markets complaints.
- Line clearance and inspect shop floor activities.
- Well versed in the In-process Quality Assurance activities which includes review of BMR, BPR, Logbooks.
- Performing Assay calculation, in-process checks during manufacturing activities as per BMR.
- Reconciliation of batch at various stages of manufacturing and packing of the batch.
- Transactions in software such as SAP, DMS, QMS, e-Logs and other applicable software.
- Review of Audit trails/ events and Alarms.
- To perform swab/ rinse sampling of manufacturing and packing equipment and submit samples to QC for testing.
- Monitoring of reject handling on shopfloor.
- Tracking of in-process samples and ensuring timely release of areas for manufacturing and packing.
- Identification of opportunity of process and practice improvement on shop floor.
- Ensure all time compliance at manufacturing, packing and warehouse shop floor.
- Immediate reporting of observed non-compliance to IPQA In charge/ QA Head.
Qualifications & Pre-Requisites
Must-Have Skills:
- B. Pharm/ M. Pharm/ M.Sc. With relevant experience in pharma.
- Must have knowledge of working on the shop floor as an in-process quality assurance.
- Exposure to various regulatory bodies such as US FDA, EU-GMP, MHRA, TGA
- Exposure to specific dosage forms like OSD, Liquid Orals, Nasal (optional)
- Effective communication, Team coordination and work in collaboration within compliance
Additional Notes
- Role is expected to work in all shifts and all days of the week.
- Expected to visit Satara, Thane, or other manufacturing sites on need basis and as per business requirements.
