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Project Lead – Quality

Act as  a critical technical resource for our plant expansion program. You will lead all QA and QMS activities for this project. You have overall responsibility for quality oversight of new equipment install, validation, and commercialization.

Responsibilities

    • Sign-off and approval of all documents from all  groups involved in project.
    • Ensures GMP rules/regulations are followed during every stage of scale-up and commercialization project
    • Develop, control, and maintain the documentation necessary to ensure compliance to regulatory requirements and internal quality procedures for new production line
    • Support Quality Operations team to ensure new line is and related products are launched in a timely manner
    • Manage change controls and their associated tasks including evaluation of impact of change on all aspects product quality

Qualifications

    • Bachelor of Science degree or equivalent. Microbiology strongly preferred.
    • 5+ years in Quality role in GMP environment – ideally in a pharmaceutical manufacturing environment
    • Background working on aseptic product development a definite asset
    • In-depth knowledge of GMP guidelines, quality systems and current HPFBI GMP related policies and directives as well as demonstrated experience in quality investigations
    • Proven planning, organizational, and time management skills
    • Excellent communication and interpersonal skills
    • Training or experience in operational excellence programs such as Six Sigma or LEAN an asset
    • Proficiency in computer applications, specifically Microsoft Office

Application Process

Application process: Please send your resume using the form below.

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