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Senior Corporate Quality Specialist at CARBOGEN AMCIS AG (Bubendorf, BL, Switzerland) | Careerkit Jobs
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CA
CARBOGEN AMCIS AG
Pharmaceuticals · il y a 27 jours
Senior Corporate Quality Specialist
Poste
Temps plein
Permanent
Senior
Modalités
Bubendorf, Bâle-Campagne
Hybride
80–100%
Exigences
5+ ans d'exp.
Master
Permis UE/AELE
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Compétences
Pharmacy
Corporate Quality Standards
CAPA management
Change Management
GxP compliance
CSV
ISO 13485
Protein biochemistry
externe Audits
Supplier selection
Material qualification
Validation
Langues
Allemand
Français
Description
Your responsibilities:
Corporate and Internal Audits process, organization, execution and follow-up
Develop, maintain and improve the Corporate Quality standard together with the corporate Management
Review/approval of change applications, deviations and related CAPAs at Corporate level
Creation/review/approval of Corporate MHB documents
Support CSV documentation review and approval
Perform and review the supplier qualification documents (questionnaire, audit CAPA plan, complaint, supplier rating data)
Responsabilités
Corporate and Internal Audits process, organization, execution and follow-up
Develop, maintain and improve the Corporate Quality standard together with the corporate Management
Review/approval of change applications, deviations and related CAPAs at Corporate level
Creation/review/approval of Corporate MHB documents
Support CSV documentation review and approval
Perform and review the supplier qualification documents (questionnaire, audit CAPA plan, complaint, supplier rating data)
Exigences
At least 5 years in a Quality Unit in a GMP or ISO 9001 environment (Drug Substances or Drug Products)
At least 5 years’ experience as auditor
Sound knowledge in quality incidents management processes
Basic knowledge in system qualification and validation
Basic knowledge in supplier qualification processes
Master in chemistry natural sciences, chemistry, biochemistry, pharmacy or medicinal chemistry or similar
Avantages
A dynamic highly motivated work environment and a high value infrastructure
Possibility to enhance, increase and further develop your key competences
Possibility to work partly from home
5 weeks of holidays at minimum
Contribution to children's day care
Insurance covering private travels
Privat accident insurance
13th Salary, Social security to 100% covered by CARBOGEN AMCIS
Bonus Program
Entreprise
CA
CARBOGEN AMCIS AG
Pharmaceuticals
