QA Associate - Eurofins Alphora
Eurofins Scientific is a world leader in the food, bio/pharmaceutical product testing, as well as environmental laboratory services and one of the global market leaders in agroscience, genomics, discovery pharmacology, and central laboratory services. With over $2 billion in annual revenues and 38,000 employees across 400 sites in 44 countries, Eurofins is a leading international group of laboratories providing an unparalleled range of testing and support services to the pharmaceutical, biopharmaceutical, food, environmental, and consumer products industries and to governments.
Eurofins Alphora is a pharmaceutical research, development and manufacturing organization in the field of active drug substances and synthetic organic chemistry. Alphora’s focus is at the early stage of API Technology Development, developing chemical processes and preparing materials for pre-clinical and clinical studies. As well, Alphora provides transformative process chemistry expertise for later stage programs and niche commercial manufacturing. Alphora has state of the art synthetic R&D labs, analytical services, GMP Kilo Labs, GMP Pilot Plant and supporting QC/QA functions. Please refer to our website for further information on this Eurofins company.
Contribute to Eurofins Alphora’s compliance with Current Good Manufacturing Practices (cGMP) through the review of Operations and Analytical Services departmental data, reports and protocols, release of batch records and intermediates, review and approval of documents, and the performance of root cause investigations.
- Liaise with production and analytical staff
- Review quality control lab data for raw materials, in-process controls, intermediates and APIs for accuracy, completeness and compliance to cGMP or other applicable regulatory standards
- Review executed batch records and production cleaning study reports for accuracy, completeness and compliance to established cGMP or other regulatory standards
- Release intermediate and API batches that satisfy quality requirements
- Review analytical data and protocols for standard qualification, stability, method qualification and method validation protocols for accuracy, completeness and compliance to GLP or other regulatory standards
- Review and approve laboratory and batch summary reports
- Review and approve quality documents such as sampling analysis and labelling forms, deviations, out of specifications, out of calibrations, and amendments
- Review and input on Standard Operating Procedures (SOPs)
- Review and feedback on deviation assessments
- Conduct root cause investigations related to deviations, out of specifications, and out of calibrations and evaluate related impact assessments and proposed Corrective Actions/Preventive Actions
- Assist in the development and establishment of suitable Corrective Actions/Preventive Actions (CAPAs) based on investigation outcomes
- Review change controls and QC specifications on a limited basis
- Contribute to QA department meetings by providing project status reports as well as identifying and leading continuous improvement activities
- Participate in opportunities to develop knowledge of cGMP and business operations
COMMUNICATION AND CONTACTS:
Within the Company: Interacts with all Personnel throughout the facility
Outside of the Company: Interacts with suppliers of raw materials, packaging and product contact materials as required. Interacts with contract testing laboratories as required.
- Minimum of an Undergraduate degree chemistry or related science
- Post-graduate diploma in Quality Assurance is an asset
- Significant experience in a Quality Assurance position working with production and/or analytical services function within the Active Pharmaceutical Ingredients (API) industry
- Extensive knowledge of cGMP requirements process chemistry knowledge
- Strong knowledge of analytical instrumentation and techniques
- Strong skills in the interpretation and trending analysis of operational and analytical data as well as instrumentation/equipment printouts
- Strong knowledge of electronic data review with emphasis on Empower 3
- Strong knowledge of method development, validation, transfer and stability requirements
- Project management knowledge and skills
- Computer application skills (e.g. MS Office)
- Clear, concise and professional communication skills
- EHS focused, Quality focused and Client focused
- Team Oriented and detail oriented
Working Conditions: This position is working in a 24/7 environment where shift work may be required. Periodic weekend, late evening, and overnight shifts are an expectation of this position.
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We thank all applicants for their interest, however only shortlisted candidates will be contacted. No agencies please!