Trainee-Instrumentation Engineer - Apotex Research Pvt. Ltd.
Conducts duties following established Apotex Research Pvt. Ltd., Bioequivalence Centre’s, Standard Operating Procedures and in a consistent manner consistent with current regulatory (TPP, USFDA, TGA, ICH…etc…) guidelines / established practices / expectations.
• Monitor and support during instruments installation.
• Assists in the preparation and revise instrument related SOPs.
• Assists in software validations.
• Perform maintenance and frequency calibration of instruments.
• Ensure all the instruments are under AMC.
• Maintain all the instruments IO,OQ ,PQ files, software validation files and frequency calibration records.
• Ensure Master list of equipments are updated.
• Maintain instrument frequency calibration master schedule.
• Arrange vendor engineers for maintenance and calibration.
• Performs additional tasks as assigned by Management.
Minimum BE / B.Tech / M.Sc Instrumentation.
• Previous instrumentation experiences an asset.
• Knowledge of or experience with analytical laboratory equipment like HPLC, LC/MS/MS etc.
• Fundamental understanding of concepts of GLP/SOPs, 21 CFR Part 11guidelines.
• Computer skills in laboratory data acquisition software(s), spreadsheets and word processing.
Industry Type Pharma/ Biotech/Clinical Research
Role Maintenance Engnr
Functional Area IT-Support, Telecom, Hardware
Education UG - B.A,B.Tech/B.E. - Instrumentation
PG - M.Tech - Instrumentation
Site No.1 Bommasandra Indl Area, 4th Phase Jigani