Senior Instrumentation Engineer

Job Summary

Under the guidance of Dy. Manager-Instrumentation, responsible for installation, maintenance and calibration of all the instruments in Apotex Research Pvt Ltd as per GMP/GLP requirements. Also responsible to generate and maintain laboratory equipment documentation.

Job Responsibilities

• Conducts duties following established Apotex Research Pvt. Ltd., Standard Operating Procedures and in a consistent manner consistent with current regulatory (GMP, DCGI- CDSCO,TPD, USFDA, TGA, ICH, GLP, EMEA) guidelines / established practices / expectations.
• Perform maintenance and calibration of analytical instruments like HPLCs, GCs, pipettes, balances, etc and maintain instruments in good working order.
• Monitor and support during instruments installations and qualifications.
• Prepare and revise instrument related SOPs.
• Assists and involve in preparation and execution of documents for software validations.
• Maintain/Oversee all the instrument related qualification files, software validation reports, routine calibration records their scheduled archiving.
• Arrange vendor engineers for maintenance/calibration and maintain necessary AMC contracts with vendors.
• Update and maintain the Master list of instruments and calibration schedules.
• Monitor freezer/environmental monitoring system and respond to the alarms.
• Documents all the work and results of all assignments as required.
• Investigates and corrects analytical, instrumental, and procedural problems, if necessary in consultation with supervisor or management.
• Ensures that all work is performed in compliance with all pertinent SOP, GLPs, GALP and Safe Work Practices.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.

Job Requirements

• Minimum BE / B.Tech / M.Sc. Instrumentation.
• 2 to 4 years of experience in Instrumentation of AR&D, Bioanlaytical lab, QC labs.
• Experience with analytical laboratory equipment like HPLC, LC/MS/MS, GCs etc. for trouble shooting, repairs, calibraitons, qualifications, etc.
• Fundamental understanding of concepts of GMP, GLP, GCP, 21 CFR Part 11guidelines.
• Computer skills in laboratory data acquisition software(s), spreadsheets and word processing.