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QC - Change Control Documentation Chemist (Brantford-Contract for 11 months)

Date: Mar 29, 2021

Location: Brantford, ON, CA, N3T 6B8

Company: Apotex

 

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, QC Documentation II works as a member of the QA department and carries out work related to documentation activities, including QC, stability, method transfer, validation and standard activities.

Job Responsibilities

 

  • Performs the following sets of activities:
    • Preparation and revision of SOPs, Analytical test methods, Master specifications, etc
    • Initiate, own and track the completion of document change control packages.
    • Proper filing, distribution and circulation of documents.
    • Tracking of SOPs in Change Control.
    • Training of Level 1 Documentation Chemist on documentation procedures pertaining to Level 1 responsibilities and duties.
    • Participate in the review of SOP’s, Test Methods, COA’s, and Analytical Summaries.
    • Review and implementation of compendial procedures.
    • Preparation of monthly reports..
  • Utilizes basic analytical knowledge and experience in carrying out their assigned activities.
  • Makes routine decisions around simple task priorities, but governed strictly in their work by SOPs.  Typically seeks the input of more higher level team members in non-routine matters.
  • Self-reviews work for accuracy and completeness. Ensures documentation is cGMP compliant.
  • Liaises with higher level QA and laboratory personnel to learn and acquire a fundamental understanding of departmental and regulatory practices. May liaise with other employees in departments across the organization to ensure correct and complete information is contained in documents. 
  • 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 duties as assigned

Job Requirements

  • Education
    • Minimum B.Sc. in Chemistry or equivalent area of study.
  • Knowledge, Skills and Abilities
    • Familiar with cGMP.
    • Familiar with USP, BP, EP and ICH guidelines and procedures.
    • Knowledge of GC, HPLC, UV, IR, etc.
    • Knowledge of wet analytical chemical techniques.
    • Ability to follow SOPs.
    • Sound experience with writing SOP’s and reports.
    • Demonstrate a basic understanding of test methods/SOPs/compendia and Certificates of Documentation.
    • Knowledge of Windows, Microsoft Word, Excel, MS Project, Chemstore/Chemstation or any suitable software.
    • Seeks performance inputs from peers and leaders to identify any performance gaps.
  • Experience
    • Preferably 2-3 years of experience in related field of chemistry.

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.

 

We have adapted our recruitment strategy to ensure our staff and applicants are safe by conducting our interviews and onboarding online.

Other measures Apotex has put into place include (but are not limited to):

•        staggering employee shifts to reduce the size of work groups

•        modifying our cafeteria space to enhance social distancing, the implementation of additional cleaning and sanitization routines

•        robust self-assessment and screening tools

•        non-surgical masks for employees working in GMP areas

•        travel restrictions

•        work-from-home policy for all employees who can perform their roles remotely

•        strict visitor screening protocol

It is important to note that while these are our protocols at this time, they are subject to change based on guidelines and regulations put in place by local and global government agencies.

For up-to-date information about Apotex’s ongoing efforts in response to COVID-19, visit: https://www1.apotex.com/global/covid-19-update or follow us on LinkedIn and Twitter