Team Member - Service Engineer QC

Minimum work experience: 3 to 6 years experience Skills & attributes &Critical exposures

Job Description

1. Laboratory Instrument Management
Installation, qualification, and maintenance of QC instruments.
Coordinate IQ/OQ/PQ activities for new equipment.
Ensure instruments are calibrated and fit for use.
Maintain instrument status labels and calibration records.
Examples of instruments:
HPLC (High Performance Liquid Chromatography)
GC (Gas Chromatography)
UV-Visible Spectrophotometer
FTIR
Dissolution Test Apparatus
TOC Analyzer
Particle Size Analyzer
2. Preventive Maintenance
Plan and execute preventive maintenance schedules.
Coordinate with OEMs and service vendors.
Track AMC/CMC contracts and service reports.
Minimize instrument downtime.
3. Breakdown Handling
Attend instrument breakdowns and troubleshoot issues.
Raise service requests with vendors.
Ensure timely restoration of equipment.
Document root cause and corrective actions.
4. Documentation & Compliance
Maintain equipment logbooks.
Review calibration and maintenance records.
Prepare SOPs related to instrument operation and maintenance.
Ensure compliance with cGMP, GLP, and data integrity requirements.
Qualification & Validation Support
Support Analytical Method Validation activities.
Execute instrument qualification protocols.
Assist during instrument requalification.
Software & Data Integrity Management
Manage chromatography software such as:
Empower
Chromeleon
Lab Solutions
User account management.
Audit trail review support.
Backup and archival of electronic data.
Utility Monitoring
Monitor laboratory utilities:
Compressed Air
Nitrogen
Water Systems
HVAC Systems
Temperature & Humidity Controls
Vendor Coordination
Coordinate with external service providers.
Follow up on quotations, service reports, and spare parts.
Verify service completion and performance.
 Regulatory Audit Support
Support USFDA, MHRA, WHO, and customer audits.
Present equipment qualification and maintenance records.
Address audit observations related to laboratory instruments.
Training
Train analysts on proper equipment operation.
Conduct refresher training on SOPs and GMP requirements.
Maintain training records.

Qualifications

Educational qualification: Graduation in Chemistry/Analytical Chemistry or Pharmacy is mandatory
Masters in Microbiology, Biochemistry,  Biotechnology, Chemistry/Analytical Chemistry or Pharmacy is preferred
Additional Certifications like CQA, CPGP, CBSP, Six Sigma, ICH Q5/Q6, Advanced Biologics Manufacturing or RAC are preferred

Functional Skills
• Regulatory Compliance
• Regulatory Filings
• Technical Documentation
• Change Control
• Laboratory Information
• Risk Management
• Chromatography
Resident Skills
• Product Quality (QA/QC)
• Current Good Manufacturing Practices (cGMPS)
• Good Laboratory Practice (GLP)
• Quality Management Systems (QMS)