BPharma QC Job at Apotex – Apply Online Now
Senior Officer, Quality Cont-ARPL-QSM AR
Date: May 17, 2024
Location: Bangalore, KA, IN, 560099
Company: Apotex
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 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 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
Responsible for Stability Management activities.
Job Responsibilities
- To ensure the smooth general 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 respect 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.
Job Requirements
Education
Minimum M.Sc / B.Pharm or any equivalent degree
Knowledge, Skills and Abilities
- Knowledge in LIMS application with respect to stability management and stability sample application
- Good skills in MS Office
- Ability to work as a team facilitator
- Dedication and willingness to work hard to achieve excellence
Experience: Minimum 2 to 4 years of experience in GMP regulated Pharmaceutical Industry
Keywords: job posting, senior officer, quality control, stability management, pharmaceutical industry. BPharma QC Job at Apotex – Apply Online Now. Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.
