Purpose

Handling Deviations, Customer Complaint investigations, Support in Audit and Compliance Management, Handling of QMS documentation

Position / Job Title

QA officer

Department

Quality Assurance

Reporting To

Section Head – QMS

Location

Satara

Years Of Experience

2-5 Years

Dosage Form

Liquid / Potent

Job Responsibilities / Deliverables

Handling Deviation, Customer complaint documentation, participating in investigation, and drafting investigation reports.

Responding to customer communications and queries.

Preparation and review of SOPs applicable for customer complaint and other job-related SOPs.

Evaluation of QMS documents.

Preparation of Site Master File.

Participate in customer and regulatory inspections and ensure customer complaint CAPA effectiveness.

Participate in self-inspections.

To audit the internal quality system as a part of self-inspection (internal audit).





Preparation of presentations and MOM for Management Review Meetings, weekly report and follow-up for action closures.

Carryout SAP transactions for code creations and master updating.

Timely and proactively escalating issues.

Qualifications & Pre-Requisites

B. Pharm / M. Pharm / M.Sc. (Chemistry) With relevant experience in pharma quality assurance.

Sound knowledge of QMS activities

Exposure to various regulatory bodies such as US FDA, EU-GMP, MHRA, TGA.

Familiarity with Liquid Oral dosage forms and/or potent formulations, OSD (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.

Flexibility to take on additional responsibilities as assigned by management

📌 Officer (Satara)
🏢 Rubicon Research
📍 Satara