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Apotex
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Sr Assoc Instrmnt Eng, AR&D-ARPL-ARDT AR

Sr Assoc Instrmnt Eng, AR&D-ARPL-ARDT AR

Apotex

2 - 4 years

3 - 8 Lacs

Bengaluru

Posted:1 day ago| Platform:

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Skills Required

GCP Analytical Pharma Instrumentation GLP Archiving GMP Licensing Environmental monitoring HPLC

Work Mode

Work from Office

Job Type

Full Time

Job Description

About Apotex Inc.

Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

For more information visit: www.apotex.com .

Job Summary

Under the guidance of Manager-Instrumentation / R&D , 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: Collaboration, Courage, Perseverance, and Passion.
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.

At Apotex, we are committed to fostering a welcoming and

accessible work environment, where all everyone feels valued, respected, and supported to succeed.

We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

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Sr Assoc Instrmnt Eng, AR&D-ARPL-ARDT AR