Senior Officer, Quality Control-ARPL-QFSA AR

☞ Apotex Research Private Limited

View: 102

Update day: 06-05-2024

Location: Bengaluru / Bangalore Karnataka

Category: Pharmacist / Pharmaceutical representatives

Industry: Pharmaceutical Biotechnology

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Job content

About Apotex Inc.

Apotex Inc. is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 8,000 people worldwide in manufacturing, R&D, and commercial operations. Apotex Inc. exports to more than 100 countries and territories and operates in more than 45 countries, with a significant presence in Canada, the US, Mexico, and India. Through vertical integration, Apotex is comprised of multiple divisions and affiliates including Apotex Inc., focused on generics; Apobiologix, a division of Apotex Inc. focused on biosimilar development; Aveva, an affiliate of Apotex Inc. fully integrated global developer and manufacturer of complete transdermal solutions; Apotex Consumer Products, a division of Apotex Inc. focused on brand name products; and Global Active Pharmaceutical Ingredients (GAPI), a division of Apotex Inc. focused on the manufacturing of active pharmaceutical ingredients (API) for Apotex and third parties. For more information visit: www.apotex.com.


Job Summary

The position entitles the incumbent to possess adequate practical and technical knowledge on the Quality control techniques and related instruments.

Job Responsibilities

The following areas shall be in preview of the desired candidate but the roles and responsibilities shall not be limited to:

  • To do the stability testing of laboratory Batches, Pivotal batches, Commercial batches and other stability samples.
  • Preparing of the stability protocols, validation protocols and finished product specifications and SOPs.
  • Analysis of stability samples, working standard qualification, maintenance of working standards and certified reference standards.
  • Online monitoring of stability chambers, photo stability chambers.
  • Analysis of Finished products, Raw materials and in process by using calibrated instruments and conventional methods
  • Calibrating instruments like pH meter, Autotitrator, UV, IR, Analytical balance and HPLC.
  • Analytical method of cleaning validation by UV-VIS SPECTROPHOTOMETER.
  • Adhere; follow and implement the Standard Operating Procedures (SOPs), health and safety practices/ policies.
  • Prepare the work sheets and protocol for the Analytical method of cleaning validation.
  • Manage change control deviations and closure of the same.
  • To co-ordinate within the groups in the laboratory and give guidance for troubleshooting

Job Requirements

Hands on experience in Analysis of Raw materials, In process and Finished products.

Experience in the formulation unit is a must.

Adequate knowledge on regulatory guidelines such as ICH, FDA, EMEA.

Candidate should be well versed with the GLP and safety practices to be followed in the quality lab.

Should possess excellent communication skills and be able to work cohesively as one of the team members.

The candidate should be willing to work in shifts.


At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

Apotex offers 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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Deadline: 20-06-2024

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