Officer

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.