Spécialiste, Assurance Qualité Emballage - Quality Assurance Specialist - Packaging

Grifols; Montreal; On-site; CAD 50,000 - 80,000; Full time

Job summary

Join a forward-thinking global healthcare company dedicated to improving lives through innovative medicines and solutions. As a QA Specialist in Packaging, you'll play a crucial role in ensuring the quality and compliance of packaging processes. Your expertise will contribute to the safety and efficacy of products that enhance health and well-being worldwide. This dynamic position offers the opportunity to work in a fast-paced environment, collaborating with various departments to uphold the highest standards of quality. If you're passionate about making a difference in healthcare, this is the perfect opportunity for you.

Qualifications

• 2-3 years experience in Quality Assurance or Quality Control in the pharmaceutical industry.
• Strong knowledge of cGMPs and FDA regulations.

Responsibilities

• Perform QA Packaging operations and final container inspections.
• Conduct inspections and release of packaging materials and finished products.

Skills

Quality Assurance

Quality Control

Analytical Skills

Problem-solving

Bilingual (French and English)

Education

DEC in General Science

Bachelor's Degree in Science

Tools

SAP

Microsoft Office (Outlook, Word, Excel)

Job description

Souhaitez-vous rejoindre une équipe internationale qui travaille à l'amélioration des soins de santé ? Voulez-vous améliorer la vie de millions de personnes ? Grifols est une entreprise mondiale de soins de santé qui, depuis 1909, travaille à l'amélioration de la santé et du bien-être des personnes dans le monde entier. Nous sommes leaders dans le domaine des médicaments dérivés du plasma et de la médecine transfusionnelle et nous développons, produisons et commercialisons des médicaments, des solutions et des services innovants dans plus de 110 pays et régions.

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Post Title: QA Specialist - Packaging

Reports to: Manager, Quality Assurance

Position Summary

The QA Specialist Packaging is responsible for performing quality functions in the packaging and 100% final contained inspection process. The incumbent is also responsible for inspection/release of packaging materials, intermediate product, and finished product. He/she may be responsible for coordinating work assignments and training of other employees. He/she is responsible for execution of the quality systems necessary to ensure that all GMP documents, systems and activities/operations are in full compliance with regulatory standards and Grifols Canada Therapeutics (GCT) requirements. Will interface with Health Canada, FDA or other inspection authorities during cGMP inspections.

Key Duties and Responsibilities

• Perform QA Packaging operations responsibilities (AQL sampling and inspection of packaged final container product, area release of packaging area, quality verification of first print and last print samples).
• Perform QA 100% Final Container Inspection responsibilities (AQL sampling and inspection of 100% visually inspected final container vials, area release of inspection area, lot reconciliation).
• Conduct Raw Material Incoming Inspection (inspection and release of packaging materials, sterile water, medical devices, and EM media).
• Ensure Label Control (inventory count and issuance of labels and inserts for the packaging process).
• Ensure retention sample receipt, SAP registration, inventory, and inspection (includes intermediates and final container products).
• Inspect and release of finished product produced at Grifols Canada Therapeutics.
• Perform various SAP transactions from the processes mentioned above.
• Annual inspection of final container retention samples.
• Perform quarterly inventory of quarantine areas.
• Perform the following day-to-day functions, but not limited to:
  • Initiate Deviations, Investigations, CAPA, Change Requests related to GMP documents / processes, as required
  • Review of Deviations, Investigations, and CAPA
  • Reviews procedures, Batch Productions Records (BPRs), logbooks, reports, and any documentation generated by Manufacturing and other departments.
  • Provide cross departmental support to production, QC, validation and engineering

Qualifications

• Education: at minimum, a DEC in general science; a Bachelor’s degree in Science is preferred.
• A minimum of 2 - 3 years’ experience in Quality Assurance, Quality Control, or equivalent in the pharmaceutical industry or GMP setting with experience in the packaging and/or 100% final container inspection process is preferred.
• Strong knowledge of cGMPs, FDA regulations and industry guidelines.
• Ability to keep neat, accurate and complete records and logs.
• Must be proactive, results-oriented, with strong organizational skills including attention de details.
• Self-starter with good work ethic and ability to work independently with minimum supervision and use good judgment, or as a contributing member of a team.
• Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever changing, fast-paced critical work environment.
• Demonstrated strong analytical, troubleshooting and problem-solving skills.
• Ability to analyze details and perform structured decision-making on a daily basis.
• Excellent verbal and written communication in French and English (the use of English is required for document exchanges and communications with departments and sites outside Quebec and Canada (USA, Spain)).
• Able to interact with all levels of personnel in a professional manner.
• Very good computer skills with basic knowledge of Microsoft programs, particularly Outlook, Word, Excel is required.