QMS

Integrated Management Systems (IMS) Compliance

• Implement and maintain IMS requirements related to manufacturing activities in line with:

• • ISO 9001 (Quality Management)
  • ISO 14001 (Environmental Management)
  • ISO 45001 (Occupational Health & Safety)
  • GMP and relevant medical manufacturing standards

• Ensure engineering practices comply with approved SOPs, work instructions, and regulatory requirements.
• Act as the engineering and packing focal point for IMS-related matters.

Engineering & Packing Documentation Control

• Maintain and control manufacturing IMS documentation including:

• • SOPs, work instructions, maintenance-related procedures
  • Risk assessments (HIRA, JSA, HAZOP where applicable)
  • Change Management
  • Validation & qualification protocols
  • SOP Reviews
  • Deviations & Investigations

• Ensure all documents are current, approved, and properly version‑controlled.
• Support document update initiatives during equipment modifications or process changes.

Audit & Regulatory Support

• Coordinate and support:

• • Internal IMS audits
  • External audits (ISO certification bodies, regulatory authorities, customer audits)

• Prepare manufacturing teams for audits and inspections.
• Track, document, and monitor closure of engineering and packing‑related non‑conformances, observations, and CAPAs.
• Conduct periodic compliance gap assessments within the manufacturing function.

Risk, Safety & Environment

• Support identification and mitigation of engineering‑related risks, including:

• • Equipment safety
  • Utility systems
  • Chemical handling systems (latex compounding, chlorination, caustic handling)

• Support environmental compliance activities related to manufacturing systems:

• • Waste water Treatment Plant (ETP)
  • Permissible abstraction volumes
  • Permissible treated water discharge
  • Environmental compliance
  • Room conditions and standard air change requirement
  • Environmental emissions
  • Waste water parameter compliance
  • Production line parameter compliance
  • Equipment calibration and compliance
  • Packing plant equipment
  • ETO
  • Stability Chambers
  • Dipping lines

• Promote safe work practices within engineering operations.

Change Control & Continuous Improvement

• Ensure all changes follow approved procedures.
• Participate in root cause analysis (RCA) of incidents, deviations, and failures.
• Support continuous improvement initiatives related to:

• • Compliance robustness
  • Documentation effectiveness
  • Audit performance
  • Repetitive engineering, capacity limitation and plant failures
  • Major plant bottlenecks

• Assist in aligning engineering practices with best medical manufacturing standards.

6. IMS Performance Monitoring & Reporting

• Prepare IMS compliance reports related to packing and engineering.
• Track key IMS metrics:

• • Audit findings
  • CAPA closure rates
  • Document compliance status

• Provide management with periodic compliance and risk status updates.

Key Performance Indicators (KPIs)

• Number of audit findings
• CAPA closure time and effectiveness
• IMS documentation compliance rate
• MOC compliance rate
• Reduction in repeat non‑conformances
• Safety incident trends (IMS scope)