:

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
1. B. Pharm / M. Pharm / M.Sc. (Chemistry) With relevant experience in pharma
2. quality assurance
3. Sound knowledge of QMS activities
4. Exposure to various regulatory bodies such as US FDA, EU-GMP, MHRA, TGA.
5. Familiarity with Liquid Oral dosage forms and/or potent formulations, OSD
6. (optional)
7. Effective communication, Team coordination and work in collaboration
8. 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