QC Reviewer - Eurofins BioPharma Product Testing Toronto Inc. - Jobs in Toronto, ON

Job Description

Company DescriptionEurofins 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 1,000 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.Job DescriptionQC Reviewer ensures that the companys quality-control standards, methods, and procedures are met, and different tasks are synchronized and prioritized between the client and Eurofins BioPharma Product Testing Toronto Inc, according to GMP requirements.Job Responsibilities include:

• Review of all laboratory-related documents in the Quality Control Laboratory e.g: finished products, bulk, raw material, and stability study products as per GMP requirements in a timely manner as per the agreed timelines.
• Review accuracy of data entries in raw data and chromatographic data management systems prior to the release of the CoA in eLIMS.
• To ensure data integrity is maintained in all the processes.
• Complete all training assignments and maintain personal training records.
• Participate in and/or lead Out of specifications Investigations OOS.
• Complete Corrective and Preventive Actions (CAPA’s).
• Participate in Internal, Customer, and Regulatory Audits.
• Assist laboratory personnel with documentation issues and provides coaching and guidance to Quality Control team.
• Provide support for Regulatory Inspections.
• Identifies and implements key process improvements to areas to enhance systems, gain site efficiencies and elevate GMP requirements.
• Notifies department supervisor/manager regarding omissions, incomplete testing results or other irregularities.
• Ensures the test methods, protocols and Standard Operating Procedures (SOPs) have been followed by the scientists/chemists during the testing.
• May be essential to perform alternating or rotating shift work (as required).
• Follows up with analysts/technicians to ensure that all necessary corrections are corrected in accordance with Good Manufacturing Practices standards.
• Audits calibration-related documents and other QC documents;
• Inputs data for trending departmental KPIs.

Qualifications

• Education: Bachelor of Science degree (or equivalent combination of education and experience such as College with 5-10 years of pharmaceutical QC testing/records review experience) in Chemistry, Biochemistry or related biological science or equivalent in job experience.
• Over 2 years of experience working in a pharmaceutical regulated Laboratory environment or Pharmaceutical Company.
• Ability to work with electronic systems (eg. LIMS) and other lab equipment to be able to perform audit trail of testing records.
• Knowledge of GC, HPLC, UV, IR, ICP-MS/OES and other analytical instrument.
• Sound knowledge of Health Canada and FDA regulations.
• Works well under pressure.
• Quality Assurance /Quality control audit background in pharmaceutical industry is an asset
• Extended hours or weekend work may be required from time to time.
• Excellent language, writing and communication skills required.

Additional InformationAt Eurofins we offer excellent full-time benefits including health & dental coverage, life and disability insurance, RRSP with 3% company match, paid holidays, paid time off.Accommodation: Persons with disabilities who need accommodation in the application process, or those needing job postings in an alternative format, may e-mail a request via the website at www.eurofins.ca.As a Eurofins employee, you will become part of a company that has received international recognition as a great place to work. To learn more about Eurofins, please explore our website at www.eurofins.caWe thank all applicants within commuting distance of GTA, Ontario for showing an interest in this position. Only those selected for an interview will be contacted.NO AGENCIES, CALLS OR EMAILS PLEASEQuick Apply

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