Quality Assurance Specialist - 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.
The QA Specialist will contribute to Eurofins Alphora’s compliance with Current Good Manufacturing Practices (CGMP) and customer service through the management of documentation, the change control process and direct client communication on Quality Assurance related topics. Additionally, as a member of the QA team, the QA Specialist shall be capable of 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.
DUTIES, SKILLS AND RESPONSIBILITIES:
- Adhere to the policies and guidelines set out in the Alphora Employee Handbook.
- Responsible for compliance with GMP guidelines and ensuring that all GMPs and SOPs are followed Thorough understanding of Current Good Manufacturing Practices (CGMP) and Alphora SOPs
- Thorough understanding of Project Management methodologies and tools to support department wide project initiatives
- Excellent communication skills and ability to guide external clients through Alphora’s processes and procedures
- Liaise with production analytical, QC and business development staff
- Point person for document control
- Working knowledge of Quality Change Management systems and experience in writing, reviewing and assessing completeness and compliance of Change Control Records
- Assigning appropriate tasks and departmental reviews to ensure quick completion of change controls
- Lead the Change Advisory Board to ensure completeness and compliance of all proposed changes
- Review and input on Standard Operating Procedures (SOPs)
- Excellent organization and time management skills, proven methods for adhering to timelines.
- 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 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
- Assist in the development and establishment of suitable Corrective Actions/Preventive Actions (CAPAs) based on investigation outcomes
- 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 clients to provide feedback on Alphora procedures and processes
- Ensures needs of clients are addressed quickly and according to cGMP
- Interacts with suppliers of raw materials, packaging and product contact materials as required.
- Interacts with contract testing laboratories as required.
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We thank all applicants for their interest, however only shortlisted candidates will be contacted. No agencies please!