Injectable Plant Maintenance - Executive /Sr. Executive | Ahmedabad

Adecco India; Ahmedabad District; Sur place; INR 700 000 - 1 100 000; Plein temps

Résumé du poste

Adecco India is seeking an Equipment Maintenance & Operations specialist to oversee sterile processing equipment, troubleshooting, and uptime in a GMP setting.

You will manage calibration and validation support, plan downtime, and ensure cGMP adherence with SOPs and real-time logs.

Additionally, you will handle QMS documents, Deviations and CAPAs, and prepare audit-ready documentation for regulators such as USFDA, MHRA, WHO and EU-GMP.

Qualifications

• Oversee maintenance and troubleshooting of sterile processing equipment and related machinery.
• Plan and execute downtime activities and preventive maintenance.
• Maintain calibration and validation records and support IQ/OQ/PQ activities.
• Ensure aseptic gowning and cleanroom discipline during maintenance tasks.
• Adhere to cGMP, SOPs and EHS guidelines for all maintenance work.
• Prepare and manage QMS documents including deviations and CAPAs.
• Be audit-ready with documentation for regulatory inspections.

Responsabilités

• Oversee maintenance of sterile processing equipment: vial washers, sterilization tunnels, filling/sealing lines, lyophilizers, and autoclaves.
• Maintain bung washing machines, capping machines, and visual inspection lines.
• Identify root causes of mechanical and electrical breakdowns to minimize downtime.
• Plan and execute shutdown maintenance activities efficiently.
• Execute calibration schedules for process instruments and sensors.
• Assist validation teams with IQ/OQ/PQ for process equipment.
• Ensure compliance with EHS guidelines and obtain necessary work permits.

Description du poste

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.