QA Suppliers
Vor 2 Tagen
Make your mark for patients
We are looking for a QA Suppliers & Operations Support Specialist to join us in our HSE & Quality Culture and Compliance department , based in our biotech and pharmaceutical manufacturing site in Bulle , Switzerland.
About the role
Actively participate in maintaining operational activities within the organization in compliance with the GMP and UCB Quality standards, mainly related to vendor management as well as in continuous improvement initiatives within HSE & Quality Culture and Compliance department.
The Suppliers & Operations Support team is responsible of GMP compliance of raw material suppliers & subcontractors.
What you’ll do
Responsible of the quality vendor process and application of it. Local process owner of this process. Management of the qualification of GMP purchased materials and associated vendors, service subcontractors (risk assessments, change controls, documentation, etc.). Management and realization of the vendors' audit (questionnaires and on site) planned for the year. Responsible for vendors' quality agreement update and creation; and ensure their successful and timely implementation. Responsible of the annual review of vendors. Responsible for the vendor’s change notification process (analysis of the document, creation of report, and responsible for change control if any). Responsible for raw materials implementation & certification (testing & sampling) regarding quality aspects Active participation in updating and maintaining vendor documentation in the electronic documentation system (documentation with expiry, documentation with periodic review, qualification documentation). Active participation in SAP configuration for vendors and purchased codes. Coordination of relationships with vendors to ensure effective following of deviations, change controls, investigations, incidents, complaints, CAPAs, etc. Approval of new analytical specification and method of new materials.I nterested? For this role we’re looking for the following education, experience, and skills
Master’s degree in Life Sciences. Extensive track record of 10 years in comparable positions within the pharmaceutical industry. Knowledge of SAP, LIMS (Laboratory Information Management System). Analytical knowledge. Demonstrated understanding of GMP environment. Very good communication, negotiation, convincing and presentations skills. Well-developed sense of discretion. Demonstrated ability to write-up scientific/technical documents. Ability to handle challenging situations, make decisions and work independently. Ability to coordinate multifaceted projects and to meet/respect critical deadlines. Sense of organization and priorities. Very good computer skills, including but not limited to, Microsoft Word - Microsoft Excel – Outlook. Languages: French and English (spoken and written).Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you
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