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Commissioning Test Protocol (CTP)

Aricent

This is a Full-time position in Toronto, ON posted June 23, 2019.

Provide local commissioning and qualification documentation support to a multinational pharmaceutical company that manufactures vaccines for global distribution.

The client has offices in over 50 countries with operations across the United States.

As a Senior CQ Engineer, the candidate would be responsible for owning and managing the creation, quality and final approval of commissioning and qualification documentation for a new bulk vaccine manufacturing facility.

Main Accountabilities Create and finalize the Commissioning Test Protocol (CTP) template, which should include test scripts capturing Installation Verification (IV), Start-up and Shake Down (SUSD) and Operational Verification (OV).

Liaise with the client representative and site Quality representative to finalize the template.

Manage the creation, quality, delivery and final approval of all CTPs (over 300 documents) leveraging the ASTM-e2500 guideline.

Supervise and provide guidance to the back office CTP work package leader and back office team, located in India, to create the remaining CTP work packages.

Manage and ensure the timely review of all executed IV and OV data packages, either by the front office or back office.

Act as the single-point-of-contact to the back office team for the CQ Leader for any questions or project delivery adjustments related to work package delivery.

Coordinate the kick-off and work package delivery meetings with the client and back office to ensure alignment and that all requirements are being met.

Review and correct the back office work packages, as required.

Organize final review and approval meetings for work packages with the client.

Proactively notify the CQ Leader of any potential delays or impacts to the quality and delivery of the work packages to enable quick risk mitigation and avoid schedule impacts.

Plan, schedule, and track progress and milestones using appropriate tools to provide that information to the CQ Leader, as required.

Ideal Candidate You must have, at a minimum 15 years of commissioning qualification experience working in biopharmaceutical manufacturing environments.

Demonstrable, hands-on work experience applying the ASTM-e2500 guidelines developing CTP protocols.

Demonstrable, hands-on work experience creating the work packages listed in the Main Accountabilities section.

Familiarity with applicable Canada, US FDA and WHO regulatory requirements.

A bachelor s degree in Engineering or Science.

A degree in Mechanical or Electrical Engineering is preferred