Senior Officer

Rubicon Research Limited; Indore District; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Rubicon Research Limited in Pithampur is seeking a Sr. Officer in Quality Assurance: In-Process Quality Assurance. You will ensure GMP compliance on the shop floor, perform IPQA checks, and support on-time product release.

The role requires 4–7 years of experience in pharma, with exposure to US FDA, EU-GMP, MHRA, TGA and familiarity with BMR/BPR, SAP, QMS, and e-Logs. Shift-based work and site visits across manufacturing locations are noted.

Qualifications

• Must have B.Pharm/M.Pharm/M.Sc. with pharma experience.
• Experience on shop floor as IPQA.
• Exposure to US FDA, EU-GMP, MHRA, TGA.
• Exposure to dosage forms like OSD, Liquid Orals, Nasal (optional).
• Effective communication and team coordination within compliance.

Responsibilities

• Line clearance and inspection of shop floor activities.
• Review of BMR, BPR, and logbooks in IPQA processes.
• Perform in-process checks and assay calculations per BMR.
• Batch reconciliation during manufacturing and packing.
• SAP, DMS, QMS, e-Logs transactions and records review.
• Review audit trails, events and alarms.
• Swab and rinse sampling of equipment and submission to QC.
• Monitor reject handling and ensure timely releases for manufacturing.

Skills

In-process QA

Shop floor experience

Regulatory exposure

Communication skills

Education

B.Pharm/M.Pharm/M.Sc.

Tools

SAP

DMS

QMS

e-Logs

Job description

Purpose

To ensure shopfloor compliance as per the GMP norms and ensure on time delivery of the products.

To ensure shopfloor compliance as per the GMP norms and ensure on time delivery of the products.

Position / Job Title

Sr. Officer

Department

Quality Assurance: In-Process Quality Assurance

Reporting To

Sr. Manager, QA

Location

Pithampur

Years Of Experience

4-7 Years

Dosage Form

Solid Oral

Job Responsibilities / Deliverables

• 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.