QA Associate Temporary contract - Eurofins BioPharma Product Testing Toronto Inc
QA Associate Temporary contract - Eurofins BioPharma Product Testing Toronto Inc
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Job Description
The 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 outofspecification 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 selfinspections 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.
Qualifications :
- 12 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 Bachelors 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.
Additional Information :
Accommodation: Persons with disabilities who need accommodation in the application process or those needing job postings in an alternative format may email a request via the website at .
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
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.
This posting is supported by AI technology to assist in screening candidates and resumes.
NO AGENCIES CALLS OR EMAILS PLEASE
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
