Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 58,000 staff across a network of more than 1000 independent companies in over 54 countries and operating more than 900 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.

In 2021, Eurofins generated total revenues of EUR € 6.7 billion, and has been among the best performing stocks in Europe over the past 20 years.

Basic Function: This role works both within and outside the company for the benefit of Eurofins and its clients. The successful incumbent will have 3+ years of experience dealing with Canadian regulatory bodies with regards to Drugs and Natural Health Products as well as integrity, strong attention to detail, and the capability to work successfully within a small team of regulatory and QA professionals, guiding our clients in industry with regards to quality assurance questions and issues.

Principal Duties:

• Preparation of Quality Assurance Reports and Standard Operating Procedures for the submission of applications to Health Canada
• Aid in the development and maintenance of quality systems that meet government regulations to ensure a high quality product is produced
• Writing, reviewing and maintaining of Standard Operating Procedures
• Training client staff on Standard Operating Procedures and Good Production Practices
• Perform quality assurance audits following GMP and GPP requirements for client facility
• Establishment and maintenance of record keeping systems and ensuring employee adherence to proper documentation practices
• Review of GMP/GPP documents including but not limited to Master Production documents, batch records, testing specifications, methods, analytical testing results, product labels, etc.
• Overseeing client premises, equipment cleanliness and maintenance, environmental conditions and product storage, and facility compliance with GPP/GMP
• Ensure that the health of employees do not put the operations and other employees at risk for health concerns
• Reviewing method validation and equipment qualification protocols and reports (e.g. water system, HVAC)
• Ensure that all lots are produced, packaged, labeled, stored and tested in accordance with regulatory requirements
• Investigation of deviations and/or out of specification results
• Ensure Corrective Action and Preventative Action (CAPA) investigations are conducted appropriately
• Any additional duties as required by supervisor.

• 3+ years of experience, ideally in production, in a quality position within the pharmaceutical or natural health product industry
• Experience writing, reviewing, and maintaining Standard Operating Procedures
• Experience investigating complaints and deviations and taking corrective and preventative actions as necessary
• Strong Understanding of GMP and/or GPP
• Familiar with Health Canada Regulations
• Experience in conducting and responding to audits (internal and external)
• Experience in method validation and equipment qualification and calibration
• Experience in assessing analytical testing results
• Excellent written and oral communication skills in order to prepare reports, write standard operating procedures and maintain communications with Health Canada - an extremely high level of English (spoken and written) will be required, and may be assessed via testing
• Excellent organizational skills and attention to detail
• Demonstrated ability to work independently and collaborate in a team-based environment
• Ability to multitask and remain calm under pressure
• High level of professionalism

EDUCATION

• Bachelor of Science Degree; Regulatory Affairs or Quality Assurance certificate is an asset
• A solid background and understanding of science is mandatory;
• Computer proficiency – Microsoft Office, especially Excel.

** NOTE: This position is being posted to recruit for ongoing future positions - candidates who apply for QA will be contacted as positions become available. Applications will be retained for up to 3 years. **