Job Description

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.

Job Summary

Responsible for assisting in execution of early development, scale-up, stability, submission, placebo batches to develop new and modified product formulations, and for packaging \xe2\x80\x93 filling and/or sealing \xe2\x80\x93 quality pharmaceutical products in a variety of finished goods formats, for Apotex Inc. The Technician works and ensures that all operations are performed in accordance with applicable procedures. the Technician \xe2\x80\x93 RD 5 acts as a knowledge resource for other members in Formulation Development \xe2\x80\x93 New Products. The Technician is proficient at basic skills in Formulation Development, and builds on more advanced skills required for optimization of processes and troubleshooting required both for Packaging and batch execution in Formulation Development plant.

Job Responsibilities
Responsible to execute Manufacturing processes and Packaging Orders (PO) following the company SOD\xe2\x80\x99s and regulatory requirements;
Participates in operating the current Packaging equipment within specifications;
Reconciles the Packaging orders with proper handling of components, bulk, and / or waste, following applicable procedure;
Leads the sanitation process and participates in the equipment set-ups to ensure an effective and efficient operation changeover;
Trains other Technicians on Packaging Equipment and Procedures as required;
Conducts basic troubleshooting of the entire Packaging operations;
Utilizes SAP system to obtain and enter necessary information with accuracy;
Performs In Process testing as requires (Particle size analysis, Bulk / Tap Density, Disintegration, Flowability and Moisture analysis tests as required.
Execute and assist to execute Process Evaluation, Process Optimization, and Submission batches as required.
Weighs, mixes, screens and blends raw materials to produce experimental trials, pilot and small-scale batches for compressed, enteric coated, and film coated tablets, capsules, pellets, powders, liquids and others as required.
Dismantles, cleans, sanitizes and assembles, as required, F.D. rooms and equipment according to established procedures to ensure GMP compliance and meet schedule requirements.
Performs in-process quality tests on trials and production batches for weight, hardness, thickness, friability, disintegration, etc. as required.
Maintains in-process testing lab in a compliant manner.
Completes and signs off all process documentation required during the execution of a batch.
Records observations on product and process characteristics during experimental trials and production batches, e.g. powder flow, capping, sticking, binding, filling, picking, etc. as required.
Recognizes out of normal situations and uses conventional problem-solving skills to troubleshoot problems, provides feedback to the supervisor, and seeks assistance as required.
Assists, as required, with troubleshooting and training on manufacturing and F.D. equipment and processes.
Reviews trial and batch documentation for correctness and completeness before forwarding to Supervisor.
Delivers in-process samples to designated area.
Deducts raw materials from inventory where required
Maintains the quality of all packaging documentation (paper & electronic) and reduces the cycle time;
Performs quality checks, following relevant procedures;
Interacts with In-Process Quality Assurance members (IPQA / QAIP), and participates in continuous improvement initiatives;
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
Grade 12 education or recognized equivalent. Diploma or in Chemistry, Pharmaceutical Technology, Engineering, or related science would be an asset
Knowledge, Skills and Abilities
Experience with product optimization an asset. Proven ability to provide, understand, and follow verbal and written work instructions without errors.
Ability to understand and achieve quantitative and qualitative standards;
Able to meet the standard physical demands in a Packaging and Formulations Development environment, including ability to lift up to 25 kg.
Experience
Minimum 3 years of packaging / manufacturing process experience in the pharmaceutical and / or food industry
Hands-on experience with email, and MS office tools; Basic understanding of computerized inventory management; SAP knowledge is an asset.

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.