Assistant Manager, QC Instrument Engineer at Amneal India
Visakhapatnam, Andhra Pradesh, India -
Full Time


Start Date

Immediate

Expiry Date

03 Jul, 26

Salary

0.0

Posted On

04 Apr, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Analytical instruments, HPLC, GC, UV, Instrument calibration, Qualification, IQ/OQ/PQ, GLP, CGMP, Preventive maintenance, Troubleshooting, LIMS, Vendor management, Documentation, Compliance, Problem-solving

Industry

Pharmaceutical Manufacturing

Description
The Assistant Manager – Service Engineer is responsible for installation, maintenance, calibration, and qualification of analytical instruments in QC/ADL laboratories. The role ensures compliance with GLP, CGMP, and company safety standards while maintaining operational efficiency of all laboratory equipment. KEY RESPONSIBILITIES: * Ensure adherence to safety norms and company policies at all times. * Comply with GLP (Good Laboratory Practices) standards. * Perform installation, qualification, and re-qualification of analytical instruments. * Prepare and implement Preventive Maintenance (PM) procedures. * Ensure all instruments are maintained as per the preventive maintenance schedule. * Handle breakdown maintenance and troubleshooting of laboratory instruments. * Maintain proper instrument usage logbooks (online/offline entries). * Coordinate with external vendors for: * Maintenance * Calibration * Installation * Manage AMC/CMC contracts for instruments. * Raise and track indents for spares, ensuring availability of critical parts. * Obtain and evaluate quotations for instrument spares and services. * Send instruments/spares to external vendors for servicing when required. * Participate in and support investigations related to instrument failures. * Update preventive maintenance schedules based on: * New equipment addition * Calibration requirements * Ensure proper upkeep and documentation of all laboratory instruments. * Attend and conduct training on: * CGMP * SOPs * Technical processes * Report to In-Charge QC / Authorized Designee. * Perform any additional responsibilities assigned by department head. * TECHNICAL SKILLS: * Strong knowledge of analytical instruments (HPLC, GC, UV, etc.) * Experience in instrument calibration & qualification (IQ/OQ/PQ) * Knowledge of GLP & CGMP guidelines * Preventive & breakdown maintenance expertise * Familiarity with LIMS / instrument software systems CORE COMPETENCIES: * Problem-solving and troubleshooting skills * Vendor management & coordination * Documentation and compliance orientation * Planning and organizational skills * Attention to detail
Responsibilities
The Assistant Manager is responsible for the installation, maintenance, calibration, and qualification of analytical instruments within QC/ADL laboratories. They must ensure compliance with GLP and CGMP standards while managing vendor contracts and troubleshooting equipment failures.
Loading...