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Performance Qualification/PQ/PQR/EMPQ/EMPQR

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 Performance Qualification (PQ) template used to validate the performance of Clean Utility Systems.

Requires creating separate protocols for PQ1 and PQ2.

Manage the review of all executed PQ data packages.

Create and finalize the Performance Qualification Report (PQR) template used to summarize the results of the Clean Utility System PQ1 PQ2.

Create and finalize the Environmental Monitoring Performance Qualification (EMPQ) template, which would include a Cleaning Efficacy Study Protocol used to verify facility cleaning efficacy and an EMPQ Protocol used to validate the performance of the FacilityHVAC system.

Create and finalize the Environmental Monitoring Performance Qualification Report (EMPQR) template, which would include a Cleaning Efficacy Study Report summarizing the results of the cleaning efficacy study and an EMPQ Report summarizing the results of the FacilityHVAC system PQ.

Liaise with the client representative and site Quality representative to finalize all templates.

Manage the creation, quality, delivery and final approval of all PQEMPQs (over 20 documents) and EMPQEMPQRs (over 20 documents), leveraging the ASTM-e2500 guideline.

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

Act as the single-point-of-contact to the back office 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 PQ 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 CCK, QSR and CTR documents.

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.

Excellent technical and communication skills.

Excellent reading and writing skills in the English language.