Distalmotion SA
.Complaint Handling & PMS Specialist (m/w/x)
VollzeitBefristeter Vertragnur vor OrtBerufserfahren
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GMP quality oversight for new product development and routine manufacturing at a life sciences company. Master's degree and health authority regulations expertise required. Work in international, multicultural teams.
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Anforderungen
- Master’s degree in life science or related
- Expertise in GMP quality assurance
- Experience with new product development/routine GMP manufacturing
- Strong knowledge of health authority regulations
- Experience in international, multicultural teams
- Fluency in written and spoken English
- Knowledge of French is an advantage
- Interpersonal, communication, and leadership skills
- Proactive approach to quality, customer/results orientation
- Analytical and problem-solving abilities
- Structured and organized workload planning
- Flexible, curious, collaborative mindset, willingness to learn
- Proficiency in CARA, TrackWise, MES, SAP LEAN
- Experience with GxP Manager, GLIMS, OsiPI or comparable systems is an advantage
Aufgaben
- Ensure manufacturing activities meet health authority requirements
- Ensure operational processes meet Merck quality standards
- Provide quality oversight for GMP operational activities
- Create robust processes
- Support compliant project delivery
- Drive continuous improvement in an international environment
- Maintain operational quality processes
- Manage deviations
- Review and approve master electronic batch records
- Review electronic batch records
- Act as local QA data manager for SAP LEAN
- Act as key user for SAP LEAN
- Provide QA oversight for manufacturing activities
- Participate in Quality on the Shopfloor
- Partner with operational teams to meet quality specifications
- Define QA requirements for operational readiness
- Help implement required documentation for operational readiness
- Participate in risk assessments
- Approve risk assessments
- Review deviations
- Approve deviations
- Follow up on deviations
- Review change controls
- Approve change controls
- Follow up on change controls
- Ensure BDC projects align with health authority expectations
- Ensure BDC operations align with Merck quality standards
- Participate in health authority inspections
- Participate in internal quality audits
- Work with colleagues across operational units
- Work with colleagues across other healthcare sites
- Work with colleagues across functional quality teams
- Provide QA guidance to operational teams
- Maintain oversight of manufacturing activities
- Help teams deliver compliant documentation
- Help teams deliver operational-readiness milestones
- Make evidence-based quality decisions
- Follow issues through to resolution
- Build trusted relationships across functions
- Contribute to a culture of quality
- Contribute to continuous improvement
Berufserfahrung
4 - 9 Jahre
Ausbildung
Master-Abschluss
Sprachen
Englisch – fließend
Französisch – Grundkenntnisse
Tools & Technologien
CARATrackWiseMESSAP LEANGxP ManagerGLIMSOsiPI
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Zur Originalanzeige bei SUSONITYÜber das Unternehmen
SU
HealthcareCorsier-sur-Vevey
Das Unternehmen entwickelt Medikamente, intelligente Geräte und innovative Technologien in Therapiegebieten wie der Onkologie, Neurologie und Fruchtbarkeit.
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