- Job Purpose To implement, maintain, monitor, and continuously improve the Quality Management System (QMS) in compliance with applicable GMP requirements, regulatory guidelines, approved company procedures, and pharmaceutical quality standards.
- Key Responsibilities

A. Quality Management System (QMS)

- Prepare, review, control, and maintain SOPs, formats, policies, specifications, and other controlled documents.
- Maintain the Document Control Register and ensure timely review and revision of documents.
- Manage document issuance, retrieval, archival, and obsolete document control.
- Ensure proper implementation of approved SOPs across all departments.

B. Document Control

- Maintain Master Document Lists and ensure the availability of current approved documents at points of use.
- Control issuance and retrieval of SOPs, BMRs, BPRs, protocols, reports, and formats, as applicable.
- Maintain records of document preparation, review, approval, and effective dates.
- Ensure records are legible, traceable, complete, and properly archived.

C. Deviation, CAPA & Change Control

- Coordinate the documentation and tracking of deviations, incidents, and non-conformances.
- Follow up on Corrective and Preventive Actions (CAPA) and verify timely closure.
- Coordinate change-control activities and ensure documented impact assessments and approvals.
- Monitor overdue actions and escalate significant quality issues to the QA Manager.

D. Training Management

- Coordinate GMP, SOP, GDP, data-integrity, and other quality-related training.
- Maintain training matrices, attendance records, assessments,



and training effectiveness records.
- Ensure employees receive training on applicable SOPs before performing assigned activities.

E. Audit & Compliance

- Support internal audits, external audits, customer audits, and regulatory inspections.
- Coordinate audit observations, responses, CAPA implementation, and closure evidence.
- Maintain audit schedules, reports, and compliance records.
- Support periodic QMS reviews and continuous improvement initiatives.

F. Quality Risk Management

- Coordinate risk assessments in accordance with approved procedures.
- Support root-cause analysis and effectiveness checks for CAPA.
- Monitor recurring deviations and quality trends and report them to the QA Manager.

G. Other QMS Activities

- Maintain records related to complaints, product recalls, quality agreements, and supplier quality, wherever assigned.
- Support preparation and review of the Product Quality Review (PQR/APR), as applicable.
- Assist in maintaining data integrity and good documentation practices.
- Ensure confidentiality, accuracy, and traceability of quality records.

3. Required Qualifications
- B. Pharmacy, M. Pharmacy, B.Sc., M.Sc., or another relevant qualification, as per company requirements.




- Relevant experience in pharmaceutical QA/QMS is preferred.
- Knowledge of GMP, GDP, SOP management, CAPA, deviation, change control, and audit documentation.
- Working knowledge of MS Word, Excel, and electronic or manual document-control systems.

4. Required Skills
- Solid documentation and record-management skills.
- Attention to detail and good analytical ability.
- Effective communication and coordination with cross-functional teams.
- Ability to manage deadlines and maintain document traceability.
- Understanding of pharmaceutical quality systems and compliance requirements.

5. Key Performance Indicators (KPIs)
- Timely review and revision of controlled documents.
- On-time closure of deviations, CAPAs, and change controls.
- Training completion and effectiveness.
- Audit observation closure within approved timelines.
- Accuracy and completeness of QMS records.
- Reduction in recurring documentation errors and overdue actions.

6. General Responsibilities
- Follow company policies, applicable GMP requirements, safety rules, and approved SOPs.
- Maintain confidentiality and ensure data integrity.
- Perform other quality-related duties assigned by the QA Manager or Head of Quality Assurance.

7. Employee Acknowledgement

I acknowledge that I have read and understood the above job responsibilities and agree to perform the assigned duties in accordance with company policies and applicable quality requirements.

Pay: ₹18,000.00 - ₹30,000.00 per month

Benefits

- Flexible schedule

Work Location: In person

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