Quality Intern

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.

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.

Position Title: Quality Intern

Reports to: Quality Manager

Position Summary

The Quality Intern supports the local Quality Manager and Pharmacovigilance (PV) contact and coordinates the processes and performs the tasks essential to ensure compliance with Health Canada regulations and guidelines, including Good Manufacturing Practices (GMP), Good Distribution Practices (GDP) and Good Vigilance Guidelines (GVP) for import and distribution of medicines and medical devices in Canada.

Key Duties and Responsibilities

• Performs QA documentation review and coordinates activities in collaboration with numerous cross-functional and inter-company personnel

• Reviews batch records for release of biologic products to the Canadian market (reviews manufacturing and testing batch records, product transport, receiving and inspection, Health Canada communication, reviews batch incidents/deviations, compiles lot release packets, and tracks progress to completion in line with Supply Chain requirements)
• Performs annual complete manufacturing record review for each product
• Documents, tracks and processes adverse events reports, product technical complaints, product returns, and incidents/deviations - liaises with customers, manufacturers and testing labs; prepares and collates documentation; enters information in electronic database system; tracks progress to completion
• Coordinates activities with GMP service providers (such as warehouses (UPS Supply Chain Services (UPS SCS), Transport Company (Skelton), manufacturing and testing sites) - including supporting investigations (e.g. product inspections, providing subject matter expert support) and reviewing deviations and corrective/preventative actions (CAPAs)
• Writes change controls, drafts SOP/document revisions, and documents for GXP training
• Reviews executed protocols and reports for validations/qualifications (e.g. for critical temperature-controlled trailers used for biological starting material and product)
• Helps maintain trackers for GXP compliance activities (e.g. training, product release, product complaints, product returns, incidents, supplier quality monitoring, customer verification).  Also maintains files of QA/PV records and controls QA documents (tracks controlled documents).
• Provides support during Health Canada inspections, customer audits, GXP subcontracted suppliers/service providers audits and self-inspections/internal audits/corporate audits (pre-audit preparation and prepares, logs and provides documentation during audits).
• Other tasks as assigned.

Qualifications

• Education: Minimum of 2 years validated in a Science College Program (min 30 credits), and in a Biopharmaceutical Sciences Program or related field preferred.
• Ability to lift or push up to 25 pounds.
• Ability to stand and/or sit for extended periods - up to four (4) hours at a time.
• Manual dexterity to perform clerical type functions such as typing, using a mouse, copying, faxing, etc.
• Ability to work at a computer and view video display terminal less than 18” away from face for extended periods - up to four (4) hours at a time.
• Ability to read and review documents for extended periods - up to four (4) hours at a time.
• Good oral and written communication skills and good interpersonal skills
• Excellent attention to detail
• Proficient in Microsoft Office, Adobe 

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Location: NORTH AMERICA : Canada : Mississauga:CATORONT - Canada Headquarters - Toronto

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