Injectable Plant Maintenance - Executive /Sr. Executive || Ahmedabad

Equipment Maintenance & Operations -

• Sterile Processing Equipment:

  Oversee the maintenance and troubleshooting of core injectable machinery including Vial Washers, Sterilization Tunnels, Vial/Ampoule Filling and Sealing machines, Lyophilizers (Freeze Dryers), and Auto-claves.

• Component Processing:

  Manage maintenance for bung washing machines, capping machines, and visual inspection lines.

• Breakdown Resolution:

  Identify root causes of mechanical and electrical breakdowns swiftly to minimize production downtime in cleanrooms (Class A/B/C/D).

• Planned Downtime:

  Plan and execute shutdown maintenance activities efficiently.

Compliance & Documentation -

• cGMP Adherence:

  Ensure all maintenance activities comply with standard operating procedures (SOPs) and current Good Manufacturing Practices (cGMP).

• Documentation Management:

  Maintain accurate, real-time logs of equipment maintenance, breakdown reports, history cards, and validation protocols.

• QMS Participation:

  Initiate and handle Quality Management System (QMS) documents, including Deviations, Change Controls, and Corrective and Preventive Actions (CAPA) related to engineering failures.

• Audit Readiness:

  Prepare documentation and present engineering systems during regulatory audits (e.g., USFDA, MHRA, WHO, EU-GMP).

Calibration & Validation -

• Schedules:

  Execute the calibration schedule for process instruments, temperature/pressure sensors, and gauges.

• Validation Support:

  Assist the validation team in Re-qualification, IQ/OQ/PQ (Installation, Operational, and Performance Qualification) of process equipment.

Safety & Cleanroom Protocol -

• Cleanroom Discipline:

  Strictly follow aseptic gowning protocols and maintain sterile area disciplines.

• EHS Compliance:

  Enforce Environment, Health, and Safety (EHS) guidelines during all maintenance activities, ensuring work permits (e.g., hot work, confined space) are utilized.