About Apotex Inc.
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. fully integrated global developer and manufacturer of complete transdermal solutions; Apotex Consumer Products, a division of Apotex Inc. focused on brand name products; and Global Active Pharmaceutical Ingredients (GAPI), a division of Apotex Inc. focused on the manufacturing of active pharmaceutical ingredients (API) for Apotex and third parties. For more information visit: www.apotex.com.
Responsible for ensuring that samples received for the QC Stability program are stored and scheduled for testing appropriately, which includes labelling, and removal of stability samples.
- Provide support in data analysis and execution of tasks related to the Stability Reduction Initiative for the QC Stability and QC Laboratory departments.
- Ensure that all samples received are logged correctly and accurately into Labware LIMS and stored in the appropriate stability chamber in a timely fashion.
- Create Labware LIMS protocols to control the testing of the stability samples and ensure that all the appropriate storage conditions and time points are included in the protocols.
- Import initial testing data and/or perform manual entry, as well as, sending samples to the QC laboratory for initial testing.
- On a monthly basis, create and maintain the monthly pull schedule.
- On a weekly basis, or as required, pull samples from the stability chambers and send to the QC laboratory for testing, and as well, perform weekly folder checks.
- Maintain detailed and accurate records of all sample movement and update inventory records accordingly.
- Run monthly inventory report in Labware LIMS and perform monthly inventory checks.
- Perform monthly inventory checks on controlled substances and provide illicit values to the site QPICs.
- Run disposal report in Labware LIMS and dispose of Stability samples for completed studies.
- Place requisition orders for batches from inventory control, when required.
- Prepare samples for shipment in accordance with established Apotex procedures, regulatory, and safety procedures to internal and external customers.
- Coordinate Commercial Stability Activities with ARPL or any other Apotex 3rd party sites to ensure shipped samples are started on the Stability Program within accordance to established procedures.
- Work with the Supervisor, QC Stability to improve departmental processes and SOP’s.
- Provide weekly status updates to the Supervisor, QC Stability.
- Works as an effective team member to meet department goals, sharing knowledge with team members and across QC. Provide cross training and support to new team members.
- Monitor training progress and ensure all training gaps are completed within MyHR for Documents, GMP, Safety, Technical and Software courses.
- Performs all work in compliance with our Code of Conduct and Business Ethics, and related policies and with the legal and regulatory requirements that apply to our job activities.
- Work as a member of a team to achieve all desired quality/compliance outcomes.
- Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements.
- Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion.
- All other relevant duties as assigned.
- Bachelor’s Degree or Diploma in Chemistry, Biology, Pharmaceutical and/or Health Sciences.
- Knowledge, Skills and Abilities:
- Working and theoretical knowledge of ICH Guidelines as it pertains to Commercial Stability.
- Understanding of GMP and GLP guidelines and related SOPs and their application in a laboratory setting.
- Knowledge of Labware LIMS, QMS Trackwise, SAP, Word, Excel, and other Windows software packages would be an asset.
- Proven organization and time management skills, as demonstrated through previous work and/or educational experiences.
- Logical and detail-oriented personality with problem solving skills.
- Ability to handle multiple work assignments and priorities in a fast-paced environment.
- Ability to work independently with minimal supervision.
- Excellent written and verbal English communication skills.
- Well balanced interpersonal skills.
- Scientific background in laboratory analysis of solid or liquid dosage forms is recommended.
Contract – 18 months
Location Richmond Hill
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.