Overview

Servier Quality Assurance Associate Temporary in Laval, QC

Servier

Branch Laval QC CA

Position:
Quality Assurance Associate
Location:
Laval, QC

QUALITY ASSURANCE ASSOCIATE. Provide support to Quality Assurance Manager. Handle Annual Product Quality Review (APQR)….

QUALITY ASSURANCE ASSOCIATE

The Servier Research Group is the second largest French pharmaceutical company in the world and the leader amongst France’s privately owned pharmaceutical firms. Servier Canada Inc., a wholly-owned subsidiary of the Servier Research Group, is currently experiencing rapid growth and expansion. Offering a dynamic work environment, Servier Canada Inc. is seeking high calibre individuals to join its team. This position (which includes an attractive benefits package) is being offered on a one-year + contract basis.

Position description

  • Ensure that the manufacturing, packaging, labelling, distribution, testing and wholesaling of drug products comply with the marketing authorization, with the Food and Drug Regulations, current Good Manufacturing Practices (GMP) and any other applicable laws, regulations and guidance documents.
  • Ensure that drug products are not sold or supplied before the quality control department has certified that each lot has been produced and controlled in accordance with the marketing authorization and of any other regulations relevant to the production, control and release of drugs products.
  • Interact with internal and external customers.
  • Provide support to Quality Assurance Manager.
  • Provide timely and appropriate reports to the Head of the Federal Regulatory Affairs Department.
  • Liaise regularly with Worldwide Regulatory Affairs and foreign sites where licensable activities are taken place.
  • Provide support for audits and Health Canada inspections and formulate, manage and follow-up on action plans taken following such activities.
  • Handle the development, maintenance and training of Standard Operating Procedures (SOP).
  • Provides initial and continuing GMP training to the relevant personnel according to their job responsibilities.
  • Maintain training records of relevant personnel.
  • Handle finished products Master binders including, among other documents: Certified Product Information Document (CPID), Product Monographs (PM), specifications, analytical methods, master manufacturing batch records, etc.
  • Handle Annual Product Quality Review (APQR).
  • Record and handle GMP data, including deviations, non-conformities, complaints, change controls, recalls, returns and corrective/preventive actions.
  • Record and handle stability-related documentation.
  • Record and handle finished products release (marketed and therapeutic units).

Requirements

  • BSc in Chemistry, biochemistry, pharmacy or Life sciences
  • 5 years experience in the pharmaceutical industry
  • Bilingual, French and English written and spoken
  • Team player
  • Well organized and detail oriented

or proceed with Standard Application Form.

Employment Type: Temporary
Location: Laval, QC, CA
Posted on: 2016-09-08
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