ST-Student, Quality Assurance - 4 months - Jobs in Brantford, ON

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 SummaryUnder the supervision of the QA Documentation Supervisor, the Student- Quality Assurance will prepare and verify all test methods, specifications, related documentation/data and protocols to implement the LIMS system and related document repository.Job Responsibilities

• Through interaction with the LIMS implementation project team, develop a thorough understanding of requirements for documentation and data preparation, entry/upload & verification activities.
• Act as the lead for ensuring documentation readiness for the LIMS related documentation/data; create a project plan with defined milestones & timelines.
• Review analytical methods, specs and other related documentation for accuracy and completeness against master lists, to support right first time data/document collection.
• Create and/or update t work instructions or SOPs to reflect changes required for LIMS.
• Provide any other requested support to the LIMS implementation team as required for LIMS and related document repository implementation.
• 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

• Knowledge, Skills and Abilities
  • Must be able to work independently and as part of a team.

• Demonstrated ability with Microsoft Word and Excel.

• Ability to follow Standard Operating Procedures (SOP).

• Experience working with LIMS and/or chemistry background an asset.
• Familiarity with Good Manufacturing Practices (GMP) an asset.

• Performs all work in support of our Corporate Values of Passion, Perseverance, Collaboration and Courage; Demonstrates strong and visible support of our values.
• Performs all work in accordance with all established regulatory and compliance and safety requirements.

COVID-19 VACCINATION POLICY: In accordance with Apotex Inc. (“Apotex”) policy, as of November 15, 2021, all individuals entering a Canadian site (including but not limited to employees, visitors, contractors and agency workers) must be fully vaccinated against COVID-19 in accordance with the current government requirements. Further, all employees must maintain all future booster vaccines as approved and recommended by Health Canada. Accommodation from these requirements for reasons pursuant to the Ontario Human Rights Code, or any other applicable law (most commonly for medical and/or religious reasons) will be reviewed and considered by Apotex.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.Quick Apply

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