Associate, Production

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.

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Job Summary

The Associate, Production PO5 is responsible for the detailed review and verification of all in-house production documents to ensure completeness and accuracy.

Responsible to ensure alignment of production practices with SOP and safety policy requirements.

Job Responsibilities

• Review executed process / production documentation (batch records (WBR), cleaning records (CR), and related forms and logbooks (inventory work sheets, raw material picklists, ECVRs, in-process test results, temperature and pressure charts) against current Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOP) to ensure that records are complete
• Review Cleaning Records and Batch Records in a timely manner, and in support of the release and shipping schedule
• Assist Chemical Operators in the completion of their documents
• Collaborate with Chemical Operators to coach them on good documentation practices to drive continuous compliance improvements
• Report any documentation errors and deviations, including deviations discovered during documentation review
• Initiate and investigate deviations; track deviation trends and provide suggestions to improve overall productivity and increase compliance
• Work closely with Technology Operations and Engineering to increase simplicity and standardization of execution instructions and production equipment
• Collaborate with QA Auditors to reconcile deviations and documentation discrepancies
• Maintain and update relevant databases such as : emissions, equipment cleaning, SAP phase times
• Complete periodic SOP review; SOP (TBR) monitoring; official copy control
• Ensure that safety procedures are complementary to operational SOPs / instructions; report any discrepancies to your supervisor
• Production and Process logbook issuance / archiving / control
• 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 High school diplomaCollege diploma or University degree in Pharmaceutical Technology, Chemistry, Engineering (or related science) is an asset
• Knowledge, Skills and Abilities Good command of the English language, both written and verbal;Demonstrated ability to communicate in a clear and effective mannerAble to follow instructions according to written proceduresProficient math skills and the understanding of significant figures and calculationsWorking knowledge with MS Office, especially Word and ExcelKnowledge of industry Good Manufacturing Principles (GMP) and Good Docuemntation Prinicples (GDP) requirements is an assetTime management, planning, prioritization, attention to detailDemonstrated analytical and problem solving skills
• Experience Minimum 2 years’ experience working in an API environmentExperience in investigations is strongly preferred

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.