We are looking for a detail-oriented QA qualified with practical experience in Quality Management Systems (QMS) and documentation management. The candidate will be responsible for overseeing, preparing, reviewing, maintaining and controlling both manual and digital quality documentation, with a major focus on Master Formula Records (MFR) and Master Batch Records (MBR).

The candidate must ensure documentation accuracy, completeness, traceability and compliance with applicable GMP requirements and internal quality procedures.

Key Responsibilities

1. MFR & MBR Documentation Management

- Prepare, review and maintain Master Formula Records (MFR) and Master Batch Records (MBR).
- Verify product formulas, manufacturing instructions, batch quantities, processing steps and applicable specifications.
- Ensure all MFRs and MBRs are accurate, approved and updated as per authorized changes.
- Coordinate with Production, QC and other relevant departments for documentation inputs and corrections.
- Ensure proper issuance, retrieval, review and archival of controlled batch documentation.

2. QMS & Documentation Control

- Manage and maintain the Quality Management System (QMS).
- Handle both physical/manual and digital quality documentation systems.
- Maintain document control, including SOPs, formats, specifications, protocols and records.
- Ensure documents are properly reviewed, approved, version-controlled and distributed.
- Maintain document master lists, revision histories and archival records.
- Track document expiry, review dates and pending approvals.

3. Digital Documentation & Data Management

- Maintain quality documents and records in digital systems.
- Ensure proper access control,



document traceability and data integrity.
- Monitor electronic document workflows, approvals and revision histories.
- Ensure appropriate backup, retrieval and retention of electronic records as per company procedures.
- Support implementation and improvement of digital QMS/document management systems.

4. GMP & Compliance

- Ensure documentation practices comply with applicable GMP requirements and approved SOPs.
- Follow good documentation practices (GDP) and data integrity principles.
- Identify documentation gaps, errors and non-compliances and coordinate corrective actions.
- Support internal audits, external audits and regulatory inspections.
- Assist in maintaining deviation, CAPA, change control and other QMS records.

5. Coordination & Monitoring

- Coordinate with Production, QC, QA and Regulatory Affairs for timely documentation.
- Monitor pending documentation and ensure timely closure.
- Conduct periodic documentation reviews to identify inconsistencies and improvement areas.
- Ensure documents are readily retrievable during audits and inspections.

Required Qualifications
- B.Sc. / M.Sc. in Chemistry, Pharmacy, Biotechnology or a relevant scientific discipline.
- 2–4 years of experience in QA, QMS or pharmaceutical/cosmetic/nutraceutical manufacturing documentation.
- Practical experience handling MFR and MBR documentation is strongly preferred.
- Knowledge of manual and digital document management systems.
- Understanding of GMP, GDP, data integrity and document control practices.

Pay: ₹254,000.00 - ₹1,240,000.00 per year

Benefits

- Cell phone reimbursement
- Commuter assistance
- Flexible schedule
- Internet reimbursement
- Paid time off
- Provident Fund

Work Location: In person

📌 Executive – QA (QMS & Documentation) (Baddi)
🏢 Maxnova Healthcare
📍 Baddi