Coordinator, Validation Supp-OLD-RHPST RCoordinator, Validation Supp-OLD-RHPST R
Apotex Inc.
Richmond Hill, ON, CA
10d ago

Apotex is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines (both generic and innovative pharmaceuticals) for patients around the world.

We are the 7th largest generic pharmaceutical company globally with more than 12,000 employees and estimated sales of approximately $3 billion.

  • Our fully integrated operation is comprised of four lines of business : Global Generics; Apobiologix; Global Active Pharmaceutical Ingredients (API);
  • and ApoPharma (Innovative Products). With our worldwide manufacturing sites, Apotex can produce up to 24 billion dosages per year.

    We produce 300 medicines in 4,000 dosages and formats that are exported to 115 countries. Apotex will spend $2 billion over the next 10 years on research and development.

    ABOUT THE ROLE

    We’re looking for a strong and proactive Validation Support Coordinator to join our team. The right candidate will be a part of the Production Support Technical Team a team that includes various analytical and strategic professionals who are passionate and driven to continuous improvement and success.

    Reporting to the Validation Support Supervisor, the Validation Support Coordinator is responsible for coordinating and executing validation related project deliverables with respect to equipment, process and sterile or aseptic Performance Qualification.

    The Validation Support Coordinator acts as a resource with process validation and production systems knowledge pertaining to filling or packaging and sterilization processes installed at the site, as well as provides support to investigations and development of study protocols as required.

    ADDITIONAL DETAILS

  • Writes, reviews and, where applicable, executes all validation risk assessments, validation protocols and validation reports related to process and sterilization validation.
  • Coordinates execution, analyses data and summarizes results for Sterilization Validation protocols.
  • Provides training on validation topics as required.
  • Reviews, initiates and recommends changes to different documents.
  • Provides troubleshooting assistance and suggest remedial and corrective actions in the case of unacceptable validation results.
  • Leads investigations by assembling the coordination cross-functional team to determine root cause and corrective actions for unacceptable validation results.

  • Operates and maintains validation equipment or instruments and consumables.
  • Assists in calibration and calibrates validation equipment and instruments as required.
  • Communicates project status updates to management.
  • Works alternate hours and shift schedules due to planned business needs.
  • CANDIDATE BACKGROUND

  • University degree in Science or Engineering
  • Minimum 3 years’ experience in Validation. Experience in sterilization validation, equipment and process qualification is an asset.
  • High level of familiarity with Excel, Word and Access is required for this role.
  • Proven experience managing multiple priorities in a fast-paced environment.
  • Experience in the pharmaceutical, food or other chemical processing industry, ideally with exposure to compounding, filling or packaging and cleaning or sterilization process for liquid dose products is an asset.
  • Excellent written and oral communion skills combined with strong interpersonal skills.
  • 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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