Description
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 35 years, Eurofins has grown from one laboratory in Nantes, France to 61,000 staff across a decentralised and entrepreneurial network of ca. 900 laboratories in 61 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.
In 2023, Eurofins generated total revenues of EUR 6.515 billion, and has been among the best performing stocks in Europe over the past 20 years.
Job DescriptionThe QA Associate will be responsible for providing documentation and technical support for designated clients under the supervision of Senior Quality Consultant and Manager, Regulatory and QA Consulting:
Responsibilities:
- Review of GMP documents (including, but not limited to, master production documents);
- Reconcile GMP documents for product lots requiring QC disposition (Batch records, Certificate of Analysis and Certificate of Manufacture, Product Label Reviews);
- Coordinate the release of product to ensure all product released are of good quality and in compliance with GMPs;
- Implement Canadian confirmatory testing for imported products;
- Review of warehouse reports;
- Ensure that products received are transported, handled, sampled, stored, and destroyed correctly;
- Ensure familiarity with client contracts, including agreed upon responsibilities;
- Ensure familiarity with client establishment licences, including approved foreign sites;
- Assess, trend and evaluate product stability programs to ensure compliance;
- Assist with deviations and out-of-specification investigations;
- Assist with Corrective Action and Preventative Action (CAPA) investigations;
- Assist with change controls and ensure they are evaluated and documented;
- Assist with evaluation of complaints, reporting of adverse events and recalls;
- Assess the disposition of damaged goods;
- Assess the disposition of returned goods;
- Assist with protocols/reports for transportation validation, warehouse temperature mapping or stability studies;
- Assist with self-inspections and external inspections;
- Assist with ongoing tracking and maintenance of GMP documents;
- Initiate and assist with updates to clients’ Standard Operating Procedures;
- Support with staff SOP training and ensure training records are compliant;
- Adhere to the clients’ Standard Operating Procedures;
- Attend audits on behalf of clients, ensuring thorough understanding of client needs and requirements;
- Adhere to Company expectation for service standard;
- Ensure accurate inventory control and distribution records;
- Attend staff meetings;
- Any other duties as delegated by the management.
- 1-2 years in a GMP environment;
- Experience working with Pharmaceuticals, Natural Health Products, and Medical Devices is an asset;
- Experience working directly with pharmaceutical products is an asset;
- Experience working in a contract laboratory is considered an asset.
- Ability to communicate fluently in French and English, both verbally and in writing, to effectively engage with clients and stakeholders.
- A Bachelor’s degree preferably in Chemistry, Microbiology, Biochemistry, or a diploma in a related field;
- Diploma/certificate in Quality Operations of Pharma products;
- A solid background and understanding of Chemistry and Microbiology is mandatory;
- Computer proficiency – Microsoft Office, especially Excel;
- Willingness and ability to travel within Canada for business trips.
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.ca
We 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 PLEASE
