QA Associate (m/f/d)

Your Profile:

• 1-2 years in GMP environment;
  
• Experience working with Pharmaceuticals, Natural Health Products, Medical Devices is an asset;
  
• Experience working directly with pharmaceutical products is an asset;
  
• Experience working in a contract laboratory considered an asset.
  
• Ability to communicate fluently in French, both verbally and in writing, to effectively engage with clients and stakeholders.
  
• A Bachelor's degree preferably in Chemistry/Microbiology/Biochemistry, or diploma in related field;
  
• Diploma/certificate in Quality Operations of Pharma products;
  
• A solid background and understanding of Chemistry/Microbiology is mandatory;
  
• Computer proficiency - Microsoft Office, especially Excel;
  
• Willingness and ability to travel within Canada for business trips.

Your Tasks:

• Review of GMP documents (including, but not limited to, master production documents);
  
• Reconcile GMP documents for product lots requiring QC disposition (Batch records, Certificate of Analysis and Certificate of Manufacture, Product Label Reviews);
  
• Coordinate the release of product to ensure all product released are of good quality and in compliance with GMPs;
  
• Implement Canadian confirmatory testing for imported products;
  
• Review of warehouse reports;
  
• Ensure that products received are transported, handled, sampled, stored, and destroyed correctly;
  
• Ensure familiarity with client contracts, including agreed upon responsibilities;
  
• Ensure familiarity with client establishment licences, including approved foreign sites;
  
• Assess, trend and evaluate product stability programs to ensure compliance;
  
• Assist with deviations and out-of-specification investigations;
  
• Assist with Corrective Action and Preventative Action (CAPA) investigations;
  
• Assist with change controls and ensure they are evaluated and documented;
  
• Assist with evaluation of complaints, reporting of adverse events and recalls;
  
• Assess the disposition of damaged goods;
  
• Assess the disposition of returned goods;
  
• Assist with protocols/reports for transportation validation, warehouse temperature mapping or stability studies;
  
• Assist with self-inspections and external inspections;
  
• Assist with ongoing tracking and maintenance of GMP documents;
  
• Initiate and assist with updates to clients' Standard Operating Procedures;
  
• Support with staff SOP training and ensure training records are compliant;
  
• Adhere to the clients' Standard Operating Procedures;
  
• Attend audits on behalf of clients, ensuring thorough understanding of client needs and requirements;
  
• Adhere to Company expectation for service standard;
  
• Ensure accurate inventory control and distribution records;
  
• Attend staff meetings;
  
• Any other duties as delegated by the management.

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