Assistant Manager, Quality Control

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.

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1. Responsible for Stability Management Activity, Documentation and Training coordination. Initiate and evaluate various investigations and excursions as per SOP. Review of data, Documents, SOP, Specifications, Protocols and Reports wherever applicable.
2. Responsible for all stability Management activities.

• Planning of stability samples to be charged.
• To ensure the smooth general day-to-day functioning of the Team activities.
• Review of Stability Protocols.
• Review of LIMS parameter in the stability projects for revised test profile (as applicable).
• Updation and authorization stability tracker entries.
• Review of inventory, chamber cleaning, stability reserve samples, chamber events logbooks, verification for completeness of stability samples receipt logbook etc.
• Review of Monthly Withdrawal Schedule.
• Ensuring the stability terminated samples disposition.
• To review various documents like Standard operating procedures, Formats, stability protocols, Specifications, Method of analysis, Analytical reports etc. for the analytical support to the Laboratories
• To monitor and co-ordination of Stability Management activities like set-up and withdrawal of Bio/pilot/Exhibit batches, commercial batches and other stability samples as per ICH guidelines.
• Responsible for LIMS related activity of stability Management (Stability Protocol Review & Approval in LIMS and samples pulling based on pulling time etc.,), Review of LIMS Data.
• To co-ordinate within the groups and partner companies for the initiating of stability study related to new as well as existing products.
• Review and co-ordination for stability related equipment qualification activity.
• Assessment of all supplier driven change controls, SOP related change controls with respect to impact on stability.
• Assessment and completion of action items for change in stability specification.
• Change control assessment of all manufacturing and packaging documents creation and revision.
• Responsible to work in coordination with Lead investigators for all stability related deviations other than laboratory deviations.
• Preparing and assessment of rate of change required for stability failure investigations required for GTA and ARPL.
• Responsible for any CAPA implementation and monitoring from stability team.
• Review of Monthly alarm report for all stability chambers.
• Review of Quarterly alarm trending report for all stability chambers.
• Generation & Review of Monthly stability compliance Report of laboratories.
• Generation & Review of Stability Summary Report for Stability Batches
• Review of all stability commitments for each products made by Regulatory affairs department for submission purpose.
• Providing data to Regulatory dept. for Annual Reports as per request.
• Results recording with respective stability batches in SAP
• Assessment of SAP Notification task for all retest batches.
• SAP notification assessment for re-pack/de-pack batches.
• Assessment and creation of "Commitment for commercial stability batches" as and when new product is launched and on quarterly basis.
• Review of the engineering M1 & M2 Notification with respective to the Stability chamber activities.
• Documentation control: ensuring archival / retrieval and updation of documentation as per regulatory compliance
• To be responsible for all activities, including cGMP/cGLP/cGXP, documentation and implementation of departmental Quality Systems.
• To provide, execute and impart training to colleagues with respect to procedures review and updating
• encourage high performance culture and a safe working environment for all employees.

• Education
  • Minimum M.Sc / B.Pharm or any equivalent degree
• Knowledge, Skills and Abilities
  • Knowledge in LIMS with respective to the Stability Managment
  • Knowledge in the Quality Systems
  • Handling of Stability Management activities
  • Experience in working online modules / software
• Experience
  • Minimum 7 to 14 years of experience in GMP regulated Pharmaceutical Industry

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.