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Food GMP Gap Assessment - Clagary, AB Canada- REF11366V - Jobs in Calgary, AB

ProPharma Group
Job LocationCalgary, AB
EducationNot Mentioned
SalaryNot Disclosed
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypeFull Time

Job Description

Company DescriptionProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.Job DescriptionClient is looking for a Food GMP Gap Assessment resource. Project is approx 3-5 days, ON SITE.

  • Client is looking to qualify their facility in Canada as both a food and drug manufacturing facility according to FDA regulations. They are looking to export products to the U.S., including veterinary food products and veterinary drugs.
Objectives:
  • Determine how they can qualify their facility as both food and drug facility, or if there would be an interferences/conflicts.
  • Gap Assessment:
    • Need to identify what FDA food regulations the facility would need to comply with and understand state of QMS for compliance
  • Remediation
    • If needed - get facility in state of compliance
  • Food GMP PAI :
    • Prepare client for FDA inspection
Qualifications
  • Qualified candidates will possess a Bachelor’s degree in scientific or engineering discipline along with 5 plus years related industry experience.
  • Proficient in Microsoft Word, Excel, Power Point and Project.
  • General knowledge of quality system elements and OSD
  • Ability to write and revise Standard Operating Procedures.
  • Effective written and oral communication skills; ability to write, type, express or exchange ideas; ability to convey information/instructions accurately.
  • Carry out duties and responsibilities with limited supervision.
  • Flexibility to work occasional weekends and evenings.
  • Ability to walk, stand and move about for long periods of time; work with equipment in the field including basic hand tools, lift and manipulate reasonable weights (approximately 35 lbs.), ability to sit and type for long periods of time.
  • Ability to plan and manage own work
  • Must be willing to travel regionally and/or nationally throughout the US.
Additional InformationWe are an equal opportunity employer. M/F/D/V***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***Quick Apply
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