About Apotex Inc.

Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 6000 people worldwide in manufacturing, R&D;, and commercial operations. Apotex medicines are accessible to patients in more than 70 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.

For more information visit: www.apotex.com.

Job Summary

To Manage the entire qualification and validation activities in the site specifically related to equipment/utility qualification, cleaning validation, process validation, packaging validation and perform the activities in compliance with the various regulatory guidelines and standards. To monitor regular activities related to quality validation and engineering as per established procedures.

Job Responsibilities
- Review and approval of documents pertaining to equipment/utility qualification, cleaning validation, process validation, hold time studies and packaging validation.




- Approval of layouts, yearly & monthly schedules, to be added planners.
- SME for Qualifications and Validations during Regulatory audits and ensuring compliance to regulatory requirements.
- Assess change controls related facility, equipment, process, utility, cleaning and packaging.
- Review & approve of standard operating procedures.
- Co-ordination and implementation of training activities of team members.
- Responsible for review of site VMP’s (Validation Master Plan) and related documents.
- Responsible for review and approval of process validation & cleaning validation protcolsand reports.
- Co-ordinate with cross functional teams in Investigations carried out at ARPL.
- Performs all work in support of our Corporate Values of Collaboration, Courage, Perseverance and Passion, Demonstrates robust and visible support of our values.
- Performs all work in accordance with all establ

📌 Senior Manager (Bengaluru)
🏢 Apotex
📍 Bengaluru