Educational Qualification
M.Sc/B.Sc/B.Pharm
Minimum Work Experience
1 to 3 years of experience.
Required Skills
- Knowledge of analytical techniques and pharmaceutical testing.
- Hands-on experience with HPLC, GC, UV, Dissolution, and related software.
- Understanding of GMP, GLP, Data Integrity, and laboratory documentation practices.
- Good investigation and problem-solving skills.
- Strong communication and teamwork abilities.
- Basic knowledge of LIMS, Empower, and Microsoft Office applications.
Key Performance Indicators (KPIs)
- On-time sample analysis and reporting.
- Compliance with GMP and Data Integrity requirements.
- Reduction in laboratory errors and deviations.
- Timely completion of investigations and assigned actions.
- Audit readiness and regulatory compliance.
- Training completion and skill enhancement activities.
Job Purpose
To perform preventive and breakdown maintenance of analytical instruments to ensure maximum equipment uptime, reliability, compliance, and uninterrupted laboratory operations.
Key Responsibilities
- Perform preventive maintenance (PM) and breakdown maintenance for analytical instruments.
- Maintain and troubleshoot analytical equipment such as HPLC, UPLC, GC, Dissolution Testers, Karl Fischer Titrators, UV-Visible Spectrophotometers, Balances, pH Meters, and other QC laboratory instruments.
- Prepare and execute annual preventive maintenance plans and PM checklists as per GMP requirements.
- Create purchase requisitions (PRs) for spares, consumables, and service requirements through SAP.
- Ensure adequate inventory of critical spare parts and consumables in the warehouse to minimize equipment downtime.
- Create, process and close maintenance work orders in SAP.
- Coordinate with OEMs and service providers for AMC, breakdown support, calibration, and spare procurement activities.
- Conduct root cause analysis (RCA), CAPA implementation and documentation for equipment breakdowns.
- Support audit readiness by ensuring compliance with GMP, GLP, Data Integrity, and Quality Management System requirements.
- Participate in equipment qualification, IQ/OQ/PQ activities and new instrument installation projects.
Required Qualifications & Experience
- Diploma / B.Tech / B.E. in Electronics, Instrumentation, Electrical, Mechanical, or related discipline.
- Hands-on experience in maintenance and troubleshooting of analytical laboratory instruments.
- Good knowledge of HPLC, UPLC, GC, Dissolution Systems, Titrators..
- Working knowledge of SAP PM Module for maintenance order creation and closure.
