Team Member - QMS & Compliance

Division

Department

Sub Department 1

Job Purpose

Support the implementation and maintenance of Quality Management Systems (QMS) and compliance activities at the site level. Assist in batch documentation review, deviation handling, CAPA tracking, audit readiness, and regulatory compliance. Ensure timely execution of quality processes and contribute to continuous improvement initiatives.

Key Accountabilities (1/6)

Batch Documentation Review

Review batch manufacturing records and ensure completeness and compliance with SOPs

Deviation and CAPA Support

Assist in documentation and tracking of deviations, change controls, and CAPAs. Participate in root cause analysis and follow-up actions

Audit and Inspection Readiness

Maintain audit trail documentation and support audit preparation activities. Ensure timely closure of audit observations

Key Accountabilities (2/6)

QMS Documentation

Maintain and update QMS-related documents such as SOPs, APQRs, and quality agreements.

Training and Compliance Monitoring

Participate in GxP training programs and monitor adherence to compliance standards.

Regulatory Support

Assist in implementing DCGI notifications and other regulatory updates

Key Accountabilities (3/6)

Risk Assessment Participation

Support risk assessment exercises and contribute to mitigation planning

Product Evaluation and Recall Coordination

Assist in product evaluation activities and support recall coordination under supervision.

Batch Documentation Review

Review batch manufacturing records and ensure completeness and compliance with SOPs.

Key Accountabilities (4/6)

Deviation and CAPA Support

Assist in documentation and tracking of deviations, change controls, and CAPAs. Participate in root cause analysis and follow-up actions

Audit and Inspection Readiness

Maintain audit trail documentation and support audit preparation activities. Ensure timely closure of audit observations

QMS Documentation

Maintain and update QMS-related documents such as SOPs, APQRs, and quality agreements.

Training and Compliance Monitoring

Participate in GxP training programs and monitor adherence to compliance standards

Key Accountabilities (5/6)

Key Accountabilities (6/6)

Major Challenges

Supporting audit readiness with limited prior notice

Key Interactions (1/2)

QA Team

Production Team

Supply Chain Team

Key Interactions (2/2)

Auditors and Inspectors

Health Authorities (e.g., DCGI)

Suppliers and Vendors

Dimensions (1/2)

• Indirect contribution to compliance across multiple product lines.
• Support in minimizing product recalls and audit observations

Dimensions (2/2)

Key Decisions (1/2)

Documentation Review

CAPA Follow-up

SOP Updates

Key Decisions (2/2)

Recommend corrections or updates to batch records

Suggest timelines and responsible persons for CAPA closure

Recommend revisions based on observed gaps or regulatory changes

Education Qualification

B.Pharm/M.Pharm

Relevant Work Experience

2–5 years in pharmaceutical QA/QMS roles, preferably in formulations or microbiology