- Gap Assessment: Evaluate current practices against standards like ICH Q10 and USFDA 21 CFR Part 211.

- Define Scope: Set the QMS boundaries across manufacturing, testing, and product lifecycles.

- Resource Allocation: Assign team roles, responsibilities, and project timelines.

Documentation and Control

- Quality Manual: Write core quality policies, objectives, and the site master file.

- SOP Management: Draft, review, and approve Standard Operating Procedures (SOPs) under strict version control.

- Data Integrity: Ensure electronic and paper records follow ALCOA+ principles.

Core QMS Subsystems Implementation

- Change Control: Review and authorize process or equipment modifications before launch.

- Deviation and CAPA: Log non-conformances, investigate root causes, and execute Corrective and Preventive Actions.

- Risk Management: Apply ICH Q9 tools (like FMEA)



to identify and mitigate operational risks.

Training and Auditing

- Training Management: Conduct training sessions to certify employee competency on new SOPs.

- Internal Audits: Perform self-inspections to check system compliance and readiness for regulatory bodies.

- Management Reviews: Present performance metrics and audit summaries to senior leadership.

Pay: ₹30,000.00 - ₹40,000.00 per month

Benefits

- Commuter assistance

- Adaptable schedule

- Health insurance

- Leave encashment

- Life insurance

- Paid sick time

- Provident Fund

Education

- Bachelor's (Required)

Experience

- Qms: 3 years (Required)

Work Location: In person

📌 Project QMS executive Pharma Background (Roorkee)
🏢 ASPIRIT VISION SOLUTION
📍 Roorkee