Pharma Job at Rubicon Research | Officer QA Role | Apply Now
Looking for a rewarding Pharma Job in the pharmaceutical industry? A leading company is hiring for a Quality Assurance Job role as a QA Officer in Satara. This exciting opportunity is ideal for candidates with experience in IPQA activities, cGMP compliance, batch record review, and pharmaceutical manufacturing operations. Candidates searching for a Pharma Job in Quality Assurance can gain valuable exposure to regulatory standards and shop floor quality systems through this role.
- Job Title: QA Officer
- Location: Satara
- Category: Quality Assurance
- reqId: 1451
About the Company
Rubicon Research is a specialty pharmaceutical company focused on developing innovative drug delivery technologies and high-quality pharmaceutical formulations. The company specializes in oral solids, liquid formulations, sachets, and other advanced dosage forms while maintaining strong regulatory compliance standards. Rubicon Research is known for its commitment to quality, research-driven manufacturing, and providing affordable healthcare solutions globally.
Job Description
To perform IPQA activities, ensure compliance with cGMP requirements, and conduct batch record review for timely product release.
Key Responsibilities
- Conduct in-process checks (IPQC) and proof checking during manufacturing and packing operations.
- Carry out pack line inspection and sampling of bulk finished and finished products.
- Perform sampling and provide execution support for process validation and cleaning validation activities.
- Ensure status labeling of materials, equipment, and areas is maintained as per SOP.
- Monitor shop floor activities through routine QA rounds and identify/report discrepancies or non-compliance.
- Verify dispensing activities to ensure compliance with BMR/BPR requirements.
- Review environmental conditions such as temperature, humidity, and differential pressure during operations.
- Ensure GDP (Good Documentation Practices) compliance on the shop floor.
- Issue, review, and reconcile Batch Manufacturing Records (BMR) and Batch Packing Records (BPR).
- Perform real-time documentation review to avoid errors and ensure right-first-time execution.
- Review audit trails of production equipment and instruments where applicable.
- Ensure completeness and compliance of batch release documentation and support archival of records.
- Identify, report, and initiate deviations observed during shop floor activities.
- Support investigation processes and CAPA implementation related to shop floor events.
Qualifications
- B. Pharm / M. Pharm with relevant experience in pharma quality assurance.
- Exposure to various regulatory bodies such as the US FDA, EU-GMP, MHRA, and TGA.
- Familiarity with Liquid Oral dosage forms and/or potent formulations, Sterile, Nasals, OSD (optional).
- Effective communication, Team coordination, and working in collaboration within compliance.
- Good understanding of GDP and Data Integrity requirements.
