Quality Assurance
1 week ago
Vivier Pharma is a Canadian Pharmaceutical Skin Care company with over 20 years of experience in the Medical Aesthetic Industry. We are currently looking for a Quality Assurance (QA) & Quality Control (QC) Coordinator to join our team based out of our Vaudreuil-Dorion location. The QA/QC Coordinator is responsible for ensuring the quality of products in accordance with all national and international governmental regulatory bodies. In addition, they are also responsible for managing regulatory aspects of products, including labelling, formulation, manufacturing conditions, and distribution This is a permanent, full time on-site position (with occasional opportunities to work from home), Monday to Friday, 8:30am to 4:30pm.
What we offer
- Competitive salary
- On-site position with occasional opportunities to work from home
- Full benefits, including telemedicine
- RRSP company matching contributions
- 3 weeks of vacation
- Paid personal/sick days
- Free product allowance
- Social events and recognition programs
- And most importantly a fun team and great environment to work in
What you will be responsible for
**QA/QC Operations**:
- Inspect all incoming and outgoing finished products and packaging components and their specific documentation for consistency, according to pre-determined established standards and guidelines
- Sample and sort finished products and coordinate testing
- Store Retained and Stability samples
- Detect any defects or other problems, identify items that do not meet requirements and notify supervisor or other responsible parties
- Review Certificates of Analyses and completed Batch Records
- File and archive all inspection related documentation in appropriate folders
- Request and assure follow-up with Third parties for documentation correction, deviation and Corrective and Preventive Actions (CAPAs) when needed
- Review & authorize product return requests
**QA/QC Systems**:
- Maintain retained sample inventory for all products produced according to procedure
- Manage testing samples for pick-up and prepare laboratory testing requisition, when required
- Review of product quality complaints, archive information and maintain the product quality complaint
- Lead the corrective / preventive action program including the verification of effectiveness
- Review labelling (artwork) in order to ensure regulatory compliance
- Download temperature and humidity data from temperature monitors and graph monthly.
- Assist with the stability program by entering test results data from the Certificate of Analysis and preparing Stability Summary Reports
- Prepare and maintain packaging specifications
- Assist the Quality Department in implementing solutions for Quality Assurance issues following Deviations, Non-Conformities or Out of Specification (OOS)
- Review pre-production batch records and ensure all change requests and updates are included
- Prepare Annual Product Quality Reviews (APQR).
- Coordinate the destruction of rejected or expired samples/products
- Ensure all Good Manufacturing Practices (GMP) documents pertaining to QA/QC are verified and archived properly
- In conjunction with the Quality team, ensure that the Company operates in compliance with all Good Manufacturing Processes (GMP) established by Health Canada
What we are looking for
- Bachelor's degree in chemistry, biology, or related discipline
- Two (2) years of previous experience in Good Manufacturing Processes (GMP)/ Good Laboratory Practices (GLP) and/or quality assurance
- Knowledge of Health Canada Good Manufacturing Processes (GMP) & FDA regulations
- Knowledge of product manufacturing
- Strong attention to detail
- Good interpersonal and organizational skills
- Proactive and a team player
- Strong writing skills
- Ability to work alone or in a team environment as required
- Strong computer skills - Word, Excel, Outlook
- English language proficiency is required for this job
If you are up for this exciting challenge and want to be part of a winning team, we would like to hear from you
Vivier Pharma is an equal opportunity employer.Vivier Pharma est une société pharmaceutique canadienne de soins de la peau qui compte plus de 20 ans d'expérience dans l'industrie de l'esthétique médicale. Nous sommes actuellement à la recherche d'un coordinateur de l'assurance qualité (AQ) et du controle de la qualité (CQ) pour se joindre à notre équipe basée à notre emplacement de Vaudreuil-Dorion. Le coordonnateur de l’AQ/CQ est responsable d’assurer la qualité des produits conformément à tous les organismes de réglementation gouvernementaux nationaux et internationaux. De plus, il est également responsable de la gestion des aspects réglementaires des produits, y compris l’étiquetage, la formulation, les conditions de fabrication et la distribution. Il s'agit d'un poste permanent à temps plein sur place (avec des possibilités occasionnelles de travail à domicile), du lundi au vendredi, de 8h30 à 16h30.
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