Coordinator, Analysup&Coord-Grd-Ardqc s
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 coordinating and tracking activities in Analytical Development (AD) and Analytical R&D Quality Control (AR&DQC) related to both New Product Development (NPD) and Product Life Cycle Management (PLCM) processes. Coordinates testing of samples and maintains inventory and records related to raw material and reference product samples used in the AD and AR&DQC.
Job Responsibilities
- Receives, logs and tracks raw material and reference product samples, requesting these samples from other departments or external sources as required.
- Maintains records for all Controlled and Targeted Substances (CTS) substances as per established procedures.
- Works with external testing laboratories on API and excipient testing as needed.
- Coordinates activities related to the generation of analytical data in support of CTA filing and Test Article release to ensure that timelines are met.
- Prepares test article packages and arranges for delivery to Apotex Clinics or Contract Research Organizations.
- Interacts with Formulation Development, and colleagues in AD and AR&DQC to coordinate API, Excipient and release/in-process testing.
- Receives and tracks in-process and finished product samples from Formulation Development and coordinates with AD and AR&DQC for completion of the requested testing.
- Provides status updates to team members as needed.
- Acts as a member of a team in Product Development to achieve all outcomes which support PD goals.
- Demonstrates Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
- Works in a safe manner collaborating as a team member to achieve all outcomes.
- Ensures personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety, Health and Environment policies, and HR policies.
- All other relevant duties as assigned.
Job Requirements
- Education
- Post Secondary education in related field
- Knowledge, Skills and Abilities
- Excellent oral and written English communication skills.
- Strong organizational and interpersonal skills.
- Familiarity with Microsoft application software, LABWARE LIMS, proficiency in SAP is an asset.
- Strong ability to work efficiently in a team environment.
- Experience
- Minimum 3 years relevant experience in pharmaceutical industry.
At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.
Apotex offers 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.