OverviewValidation Associate in Laval, QC
ProMetic Sciences de la Vie inc.
Branch Laval QC CA
with all aspects of validation and quality assurance, which relate to a pharmaceutical development organization. Directly relevant experience with biologics or…
ProMetic BioProduction Inc. (“PBP”) undertakes the development and manufacture of high-value plasma-derived therapeutic biosimilars for ProMetic’s current and future clients in a state of the art facility.
The Validation service of ProMetic BioProduction Inc. is looking for an Associate, Validation to work at its plant in Laval, Quebec. Under supervision of the Director, Quality System, the Associate, Validation will be responsible for all validation/qualification and calibration activities at the ProMetic BioProduction, Inc
The mandate of the Associate, Validation will be mainly:
Participate in all validation/ qualification activities;
Participate in the calibration/certification program;
Compose, review and approve validation protocols and reports associated with equipment, utilities/ facilities, methods ;
Coordinate validation work execution with various departments and contractors and coordinate multiple small or large projects;
Ensure equipment remain in a calibrated state in accordance with company policy and legislative requirements;
Review and approve SOPs, calibration records, equipment specifications;
Assist in writing, reviewing and approval ProMetic of SOPs;
Participate in validation deviation investigations to resolve execution or result discrepancies;
Provide QA input to various other projects on site as required in the maintenance of company Quality Systems with respect to validation, and compliance or as deemed necessary by Quality Assurance Management;
Participate in supplier qualification audit, GXP and technical topics;
Other related duties/responsibilities as required or assigned by the Supervisor.
The selected candidate will hold a Bachelor degree in Chemistry, Biochemistry, Biology, or in a related field with a minimum of two (2) to five (5) years knowledge and working experience with all aspects of validation and quality assurance, which relate to a pharmaceutical development organization. Directly relevant experience with biologics or biotechnology derived products is required. The candidate must have a thorough knowledge and understanding of Canadian, US FDA and European regulations (GMP), as well as experience with GLPs, GCPs and ICH regulations and guidelines. Excellent knowledge of English (oral and written) and French, (oral) is essential. Ability to operate both independently and in cross-functional team settings including qualified professionals of other departments is required.
ProMetic offers a competitive compensation, a flexible work schedule and a casual working environment.
To apply, please send a cover letter and copy of your resume to [email protected] with the following reference: VALID-PBP. ProMetic is an equal opportunity employer. Only chosen candidates will be contacted for an interview . For more information about ProMetic, visit our website www.prometic.com .
Employment Type: Full Time
Location: Laval, QC, CA
Posted on: 2014-09-13