- 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
Advantages:
- Commuter assistance
- Flexible schedule
- Health insurance
- Leave encashment
- Life insurance
- Paid sick time
- Provident Fund