Job Title:
Assistant Manager, Quality Control
Date Posted: August 19, 2025
Location: Bangalore, Karnataka, India, 560099
Company: Apotex
Company Overview:
Apotex Inc. is a Canadian-based global healthcare company committed to producing high-quality, affordable medicines. Employing nearly 6,000 people worldwide across manufacturing, R&D, and commercial operations, Apotex provides medicines accessible in over 70 countries. The company focuses on the development and sale of generic, biosimilar, and specialty products through vertical integration.
For more information, visit: www.apotex.com
Job Summary:
Responsible for overseeing Stability Management activities, documentation, and training coordination. Initiate and evaluate investigations and excursions as per SOPs. Review data, documents, SOPs, specifications, protocols, and reports related to stability management.
Key Responsibilities:
Plan and schedule stability sample charging.
Ensure smooth day-to-day functioning of team activities.
Review stability protocols and revised LIMS parameters related to stability projects.
Update and authorize stability tracker entries.
Review inventory, chamber cleaning logs, reserve samples, stability sample receipt logbook, and chamber event logbooks.
Review monthly withdrawal schedules and ensure proper disposition of terminated stability samples.
Review analytical support documents such as SOPs, formats, stability protocols, specifications, methods of analysis, and analytical reports.
Monitor and coordinate stability management activities, including setup and withdrawal of bio/pilot/exhibit batches, commercial batches, and other stability samples per ICH guidelines.
Manage LIMS-related stability activities: protocol review & approval, sample pulling, and data review.
Coordinate with internal groups and partner companies for initiating stability studies on new and existing products.
Review and coordinate stability-related equipment qualification activities.
Assess supplier-driven and SOP-related change controls for their impact on stability.
Complete action items related to changes in stability specifications.
Assess change controls related to manufacturing and packaging document creation/revision.
Collaborate with lead investigators on stability-related deviations (excluding laboratory deviations).
Prepare and assess rate of change for stability failure investigations for GTA and ARPL.
Implement and monitor CAPAs from the stability team.
Review monthly and quarterly alarm reports and trending for all stability chambers.
Generate and review monthly stability compliance reports and stability summary reports for batches.
Review stability commitments for products submitted by the Regulatory Affairs department.
Provide stability data to Regulatory Affairs for annual reports upon request.
Record results for stability batches in SAP.
Assess SAP notification tasks for retest and re-pack/de-pack batches.
Manage commitments for commercial stability batches during new product launches and quarterly reviews.
Review engineering M1 & M2 notifications related to stability chamber activities.
Manage documentation control, including archival, retrieval, and updating as per regulatory compliance.
Ensure compliance with cGMP, cGLP, and cGXP standards in departmental quality systems.
Provide training on procedure review and updates to colleagues.
Promote a high-performance culture and maintain a safe working environment.
Education:
Minimum M.Sc. or B.Pharm degree or equivalent.
Knowledge, Skills & Abilities:
Proficient in LIMS with respect to Stability Management.
Strong understanding of Quality Systems.
Experience handling Stability Management activities.
Skilled in working with online modules and software platforms.
Experience:
Minimum 7 to 14 years of experience in a GMP-regulated pharmaceutical industry.
Equal Opportunity & Accessibility:
Apotex is committed to fostering an inclusive and accessible work environment. Accommodation is available for applicants with disabilities throughout the recruitment process. Please notify if accommodation is needed during interview or testing.
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