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.
Post : Senior Officer, Quality Cont-ARPL-QSM AR
Job Summary
Responsible for Stability Management activities.
Job Responsibilities
• To ensure the smooth general the day-to-day functioning of the Stability Management.
• To generate documents and maintain records related to stability activities.
• Routine monitoring of all functional areas to ensure adherence to the SOPs.
• To perform the Stability Management activities like set-up and withdrawal of Bio/pilot/Exhibit batches, commercial batches and other stability samples as per procedures.
• Responsible for maintaining the Stability Chambers with respective stability samples Set-up and Withdrawal and maintaining records online such as Monitoring of Temperature and Relative Humidity for stability / Cold chambers, LIMS & Stability Samples Database.
• Preparation of Stability Protocols for the Stability batches.
• Generation/preparation of Stability Summary Reports for the Stability batches
• Responsible for the Receipt of the stability samples from the Production, Formulation development, External customers and maintaining of respective record.
• Monitoring of Temperature and Relative Humidity for Stability samples storage areas and recording of respective logbooks.
• Responsible for the removal of Stability study termination samples and Disposal of the samples as per the procedures.
• Stability Samples Inventory Verification as per the Procedure.
• Responsible for the worksheet requisition and material with respective to the Stability activity.
• Preparation of regulatory audits and compliance for the same.
• Updation of Product Specifications & Methods (LIMS parameters) in LIMS Stability Projects
• 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.
Candidate Profile
M.Sc / B.Pharm or any equivalent degree
Minimum 2 to 4 years of experience in GMP regulated Pharmaceutical Industry
Knowledge in LIMS application with respect to stability management and stability sample application
Good skills in MS Office
Ability to work as team facilitator
Dedication and willingness to work hard to achieve excellence
Additional Information
Experience : 2 to 4 years
Qualification : M.Sc / B.Pharm
Location : Bangalore, KA
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Quality Cont
End Date : 20th June, 2024
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