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 recent 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
Perks
Commuter assistance
Adaptable schedule
Health insurance
Leave encashment
Life insurance
Paid sick time
Provident Fund