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Chemist Ii, Validation (Brantford)

October 24 2020
Industries Pharmaceutical, Biotechnology
Categories Chemistry, Pharma, Biotech, Sciences, R&D, Quality assurance and control, Validation
Brantford, ON

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

The Chemist II, Validation in Analytical Operations stream (Quality Unit) contributes to the timely delivery of method transfer and method validation/review activites to support production and stability program. Performs daily tasks as assigned by the Team Lead.

Job Responsibilities
  • Fully responsible for method transfer and method validation review/approval activities with AO/QC, through co-ordination.
  • Schedule and coordinate execution of method transfer activities to meet defined timelines; monitoring progress.
  • Ensure validation of analytical methods, equipment cleaning validation, and to ensure that coupon recovery factor determination is performed according to requirements established in the related protocol, SOP and ICH guidelines.
  • Reviews and approves Analytical Method Validation protocols and reports; assesses technical accuracy, completeness, and compliance to internal procedures and GMP.
  • Writes, revises and/or reviews SOPs, protocols, and reports.
  • Ensure proper storage of Validation / Method Transfer data, analytical data and information. Supervise maintenance of reports, and maintain Method Transfer notebooks as required.
  • Monitor progress towards deadlines in Validation and Method Transfer areas. Make routine decisions around task priorities.
  • Prepare monthly reports and provide updates on Validation / Method Transfer status on request.
  • Liaise with management relative to potential amendments to departmental procedures. Liaise with peers or higher level team members in departments across the organization (R&D, QA).
  • Involved in retrieval of documentation related to audits of Method Transfer, Method Validation and Cleaning Validation; and conducts appropriate follow-up investigations of issues arising from audit findings to determine root cause and suggest corrective action.
  • 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
    • Minimum B.Sc. in Chemistry or equivalent area of study
  • Knowledge, Skills and Abilities
    • Sound knowledge with cGMP.
    • Well acquainted with USP, BP, EP and ICH guidelines and procedures.
    • Proven record of analytical skills and knowledge of using GC, HPLC, UV, IR, DSC, etc.
    • Knowledge of Windows, Microsoft Word, Excel, and Access, instrumentation operating software, or other suitable software.
    • Must demonstrate an in-depth understanding of method validation/cleaning validation/method transfer/test methods/SOPs/compendia.
    • Excellent verbal and written communication skills.
    • Proficiency in writing and reviewing SOPs, protocols, and reports.
    • Proficiency in instrumental analysis including GC, HPLC, ICP, and HPIC.
    • Ability to schedule and meet defined targets.
    • Ability to follow SOPs.
  • Experience
    • Preferably 3-5 years of experience in related field of chemistry or in a Pharmaceutical or equivalent industry
    • A minimum of 3-5 years practical experience in analytical method transfer and method validation program requirements

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.

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