Quality Officer - Commercial Stability Laboratory

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

Analysis of Stability samples, Method verification, Method transfer sample and Instrument qualifications as assigned in timely manner.

Job Responsibilities

• Analysis of Stability analysis, Method verification, Method transfer samples as per method of Analysis by adhering to the Regulatory Procedures.
• To be responsible for all activities in the Commercial Stability Laboratory, including cGLP, documentation and implementation of departmental Quality systems.
• Qualification and calibration of analytical instruments as per procedure.
• Performing timely analysis of samples on priority basis.
• To ensure compliance of cGLP by following applicable procedures in Laboratory.
• Compliance to GLP, SOPs, Test Procedures and Protocols etc.
• Participate in the activities ensuring all time audit readiness in the lab.
• Assist in preparation, review and revision of SOPs, test procedures as required.
• Performs all work in accordance with all established regulatory and compliance and safety requirements.
• Coordinating the issues related to the specifications/ worksheets/ other documents with concern department and take efforts to resolve the same immeadiately.Identify the causes and recommend/implement solutions with management oversight.
• 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 by Assistant Manager.
  
  

Job Requirements

• Education
• Minimum MSc/BPharm 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 1 to 2 years of experience in GMP regulated Pharmaceutical Industry.
  

At Apotex, we are committed to fostering a welcoming and accessible work environment, where all everyone feels valued, respected, and supported to succeed.

We offer 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.

---