QA QSM

1. 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.

2. 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

• Strong 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: ₹22,000.00 - ₹45,000.00 per month

Benefits:

• Flexible schedule
• Food provided
• Health insurance
• Leave encashment
• Life insurance
• Paid time off

Work Location: In person