qa biotech specialist à Fribourg

publié
contact
Coralyne Saint-Cirel, Genève Professionals Health Care & Life Sciences
type d'emploi
permanent
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job details

publié
lieu
fribourg
secteur
Life Sciences
type d'emploi
permanent
référence
11797
contact
coralyne saint-cirel, genève professionals health care & life sciences
téléphone
058 201 54 40
postuler >

description du poste

Major Accountabilities:

- Maintain, develop, and collaborate to the Organization “QA Biotech” within the Quality Assurance department in alignment with the Site Vision, Mission, Long Term Plan. - Responsible for compliance activities and quality strategies for projects with regards to technical operations related to manufacturing of biological actives Drug Substances (DS) in compliance with national and/or international regulations, guidelines (GMP), and relevant Quality Policies - Manage and approve routine manufacturing operations: Deviations, CAPAs, Change Control, audits & Inspections support and batch record review - Ultimately, act as responsible Person delegate for DS product release - Responsible to proactively support operations (on the floor) in order to identify, develop, and implement quality and operational excellence improvements in response to business requirements and/or technical changes and/or regulatory requirements to drive and enhance site competitiveness in alignment with Quality Standards. - Maintain a quality culture in close cooperation within QA, internal partners, and external partners.

Your Profile: - Qualified to Master degree level in life science (biology or chemical), or Pharmacist - Proven QA work experience in biotech manufacturing environment - Experience operational production and ability to work closely with operational teams in manufacturing area - Demonstrated understanding of the GxP environment and technical competence in core areas of Biotech product manufacturing - Ambassador for quality and continuous improvement culture implementation at shop floors level - Languages: French & English (written and spoken)