QMS Documentation

Preparation, review, and maintenance of SOPs, quality manuals, and other QMS documents.

Ensure proper document control and timely revision of SOPs.

Maintain records as per GMP and regulatory requirements.

Deviation Management

Handling of deviations, incidents, and non-conformances.

Coordinate with concerned departments for deviation investigation.

Ensure timely closure of deviations with proper CAPA.

CAPA Management

Preparation and monitoring of Corrective and Preventive Actions (CAPA).

Follow up with departments for CAPA implementation.

Verify the effectiveness of CAPA actions.

Change Control Management

Initiate, review, and monitor change control requests.

Assess the impact of changes on product quality and GMP compliance.

Ensure proper approval and implementation of changes.

Audit Management

Coordinate internal audits, external audits, and regulatory inspections.

Prepare audit schedules and maintain audit-related documentation.

Follow up on audit observations and ensure timely closure.

Training Management





Maintain employee training records.

Coordinate GMP, SOP, and compliance training.

Monitor training completion status.

Quality Risk Management

Conduct risk assessments using tools like FMEA.

Identify potential quality risks and implement mitigation plans.

Product Quality Review (PQR/APR)

Coordinate preparation of Annual Product Quality Reviews.

Collect data related to deviations, complaints, batches, and stability.

Customer Complaints & Regulatory Compliance

Support investigation of customer complaints.

Ensure compliance with WHO-GMP, Schedule M, and other applicable regulatory guidelines.

Quality Metrics & Reporting

Prepare monthly QMS reports.

Monitor KPIs related to deviations, CAPA, change controls, and audit observations.

Ensure timely closure of quality events.

Pay: ₹25,000.00 - ₹35,000.00 per month

Work Location: In person

📌 QMS Sr. Executive(pharma background) (Roorkee)
🏢 AK GROUP
📍 Roorkee