- Toronto, ON, Canada
Eurofins Scientific is an international life sciences company, which provides a unique range of analytical testing services to clients across multiple industries. The Group believes it is the world leader in food, environment, 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 for supporting clinical studies. In addition, Eurofins is one of the leading global emerging players in specialty clinical diagnostic testing.
In 2018, Eurofins generated 4.2 billion Euro proforma turnover in 800 laboratories across 47 countries, employing about 45,000 staff.
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.
- 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
- 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. **