Senior Officer Quality Con-ARPL-QFSA AR

About Apotex Inc.

Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

For more information visit: www.apotex.com.

Job Summary

Perform and report the analysis of In-Process samples, finished products, Stability samples and Cleaning Validation.

Job Responsibilities

• To ensure timely completion of analysis and data completion for the same.
• To be responsible for all activities in the Quality Control Laboratory, including cGLP, documentation and implementation of departmental quality systems.
• To perform the in-process/finish product/stability testing of laboratory Batches, Commercial batches, other stability samples and Cleaning validation.
• To Prepare Stability Trend Reports for Laboratory samples.
• To collect and maintain various laboratory samples.
• To generate and maintain records related to laboratory samples.
• Works as a member of a team to achieve all outcomes.
• Performs all work in accordance with all established regulatory and compliance and safety requirements.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• To assist the Senior Analyst / Team Leader/Group Leader in the day-to-day functioning of the Quality Control Laboratory.
• 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 duties as assigned.
  
  

• Education
• M.Sc\BPham or any equivalent degree
• Knowledge, Skills and Abilities
• Effective command over verbal and written communication with good interpersonal skills.
• Command on Microsoft-Office (Word, Excel).
• Able to prioritize the tasks.
• Best in effective planning of work activities to meet the time lines.
• Experience
• Minimum 2 to 4 years of experience in GMP regulated pharmaceutical industry.