1. Job Purpose

The QMS skilled will be responsible for establishing, maintaining, monitoring, and continuously improving the Quality Management System of the organization in compliance with applicable GMP requirements, regulatory expectations, company policies, and quality standards.

The role will ensure that quality-related systems such as deviation management, CAPA, change control, document control, risk management, training, audits, complaints, and quality metrics are effectively implemented and maintained.

The position requires the ability to challenge non-compliant practices professionally and independently while maintaining good coordination with other departments.

2. Key Roles & Responsibilities

A. Quality Management System

- Implement and maintain the organization's Quality Management System in accordance with applicable GMP and regulatory requirements.
- Ensure effective implementation of quality policies, procedures, SOPs, and quality standards across departments.
- Monitor the effectiveness and compliance of QMS processes.
- Identify gaps in existing quality systems and recommend improvements.
- Support continuous improvement initiatives within the quality system.
- Prepare and review QMS-related reports and quality metrics.
- Coordinate with cross-functional departments to ensure timely closure of quality-system activities.

B. Deviation Management

- Review and manage planned and unplanned deviations from approved procedures, processes, specifications, and instructions.
- Ensure deviations are properly documented, investigated, and closed within the defined timeline.
- Review root-cause analysis and ensure that the identified root cause is scientifically justified.
- Assess product, process, and compliance impact associated with deviations.
- Ensure appropriate corrective and preventive actions are identified.
- Monitor overdue deviations and escalate delays to the appropriate management.
- Identify recurring deviations and initiate appropriate improvement actions.

C. CAPA Management

- Manage the Corrective and Preventive Action (CAPA) system.
- Review CAPA proposals for adequacy and effectiveness.
- Ensure CAPAs address the actual/systemic root cause rather than only the immediate problem.
- Track CAPA implementation and closure within approved timelines.
- Conduct or coordinate CAPA effectiveness checks.
- Identify recurring issues and recommend additional actions where required.
- Maintain appropriate CAPA records and reports.

D. Change Control

- Coordinate and monitor the Change Control system.
- Review proposed changes related to:
- Manufacturing processes
- Equipment
- Facilities
- Raw materials
- Packaging materials
- Specifications
- Analytical methods
- SOPs and documents
- Computerized systems
- Ensure appropriate impact and risk assessments are performed.
- Coordinate with relevant departments to define implementation requirements.
- Assess the need for qualification, validation, regulatory assessment, stability studies, training,



or document updates.
- Monitor implementation and closure of change controls.

E. Document Control

- Ensure controlled documents such as SOPs, specifications, policies, forms, protocols, and records are properly managed.
- Coordinate preparation, review, approval, issuance, revision, and archival of controlled documents.
- Ensure only current and approved versions of documents are available at points of use.
- Control obsolete documents and prevent unintended use.
- Maintain document master lists and revision histories.
- Ensure documents are periodically reviewed as per the defined schedule.

F. Training & Training Compliance

- Coordinate the organization's GMP and QMS training program.
- Ensure employees receive appropriate training before performing assigned activities.
- Monitor training completion and identify overdue training.
- Coordinate training related to new/revised SOPs and procedures.
- Maintain training records and matrices.
- Evaluate training effectiveness where applicable.

G. Audit & Inspection Support

- Support internal audits, customer audits, regulatory inspections, and external audits.
- Coordinate preparation of documents and records required during audits/inspections.
- Track audit observations and ensure appropriate CAPA is developed.
- Monitor timely implementation and closure of audit commitments.
- Support preparation of responses to audit observations.
- Identify recurring audit observations and recommend systemic improvements.
- Maintain audit-related records.

H. Risk Management

- Support implementation of Quality Risk Management principles.
- Coordinate risk assessments related to processes, products, equipment, changes, deviations, and quality systems.
- Ensure appropriate risk assessment tools/methodologies are used.
- Review identified risks and proposed mitigation measures.
- Monitor implementation of risk-control actions.
- Support periodic review of significant quality risks.

I. Product Quality / Quality Review

Depending on the organization's system, support preparation and review of:

- Product Quality Reviews (PQR/APQR)
- Quality metrics
- Deviation trends
- CAPA trends
- OOS/OOT trends
- Complaint trends
- Stability trends
- Change-control trends
- Recurring quality issues

Identify adverse trends and escalate significant quality concerns to management.

J. Complaint & Investigation Support

- Support the quality complaint management system.
- Coordinate investigation of product quality complaints with relevant departments.
- Ensure investigations are completed within defined timelines.
- Review investigation reports and root-cause analysis.




- Ensure appropriate CAPA is identified where required.
- Monitor complaint trends and recurring issues.

K. Data Integrity & Compliance

- Promote compliance with data integrity principles, including ALCOA+.
- Ensure quality records are complete, accurate, traceable, and maintained appropriately.
- Identify potential data-integrity risks and escalate them appropriately.
- Support investigations involving documentation or data-integrity concerns.
- Ensure electronic and paper-based quality records are appropriately controlled.

L. Quality Metrics & Management Reporting

- Prepare periodic QMS performance reports.
- Track key quality indicators such as:
- Open/overdue deviations
- CAPA status
- Change-control status
- Audit observations
- Training compliance
- Complaints
- OOS/OOT trends
- Document review status
- Identify negative trends and communicate them to management.
- Support preparation of management review presentations and reports.

3. Cross-Functional Responsibilities

The candidate will work closely with:

- Production
- Quality Control
- Engineering
- Warehouse
- Regulatory Affairs
- R&D;
- Supply Chain
- IT/CSV, where applicable
- Microbiology
- Validation

4. Key Skills Required

Technical Skills

- Good understanding of GMP and pharmaceutical QMS
- Deviation management
- CAPA
- Change Control
- Root Cause Analysis
- Risk Management
- SOP/document control
- Audit management
- Data Integrity / ALCOA+
- Quality metrics and trending
- Investigation skills
- Knowledge of regulatory expectations

Soft Skills

- Strong analytical and problem-solving ability
- Good written and verbal communication
- Attention to detail
- Good documentation skills
- Ability to work with cross-functional teams
- Ability to manage multiple activities and timelines
- Good decision-making ability
- Ability to handle pressure
- Strong quality and compliance mindset
- Leadership and team-management skills for managerial positions

5. Qualification & Experience

Education:

- B.Pharm / M.Pharm
- B.Sc / M.Sc in relevant pharmaceutical/science discipline
- Other relevant qualification may be considered based on experience

Experience:

- [X–X] years of experience in Pharmaceutical QA/QMS
- Experience in GMP-regulated manufacturing environment preferred.
- Experience in handling deviations, CAPA, change control, audits, and documentation is essential.
- Experience with regulatory/customer audits will be an advantage.

6. Key Performance Indicators (KPIs)

The role may be evaluated based on:

- Timely closure of deviations
- Timely CAPA closure
- CAPA effectiveness
- Change-control closure within timelines
- Reduction in recurring deviations
- Audit observation closure
- Training compliance
- Document review compliance
- QMS compliance
- Quality trend improvement
- Timely completion of PQR/APQR activities
- Reduction in overdue QMS actions

Benefits:

- Paid time off
- Provident Fund

Work Location: In person

📌 QMS Executive / Senior Executive / Manager (Baddi)
🏢 Maya Biotech
📍 Baddi