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Agnieszka Kawalec
Talent Acquisition Consultant at Coopers Group AG - Life Science
Start date: As soon as possible
Duration: 1 year/possible extension
Workload: 100%
Responsibilities:
QA supervision of qualification- and validation-activities for GMP-relevant equipment (including CSV), Analytics, infrastructure
Review and approval of GMP relevant Documents like Plans, Reports, SOPs, Change Control, Discrepancy Management, CAPA (corrective action and preventive action), Risk Analysis
Assist management in regulatory inspections and performing internal as well as partner audits Ensure adherence to cGMP requirements and Roche policies and standards in technical development functions
Apply advanced theory, quality principles, expert judgment and cross functional expertise to address complex problems independently
Provide technical and quality assurance input to review and approval of manufacturing and Quality related documents as appropriate, Serve as a Subject Matter Expert (SME) in support of departmental functions and build partnerships and collaborate with stakeholders in other areas of the business to ensure success of the quality.
Leading of complex risk assessments Leading resolutions of quality issues and establish work priorities to meet targets and timelines
Creation and periodic review of quality agreements (QAGs) with contract organizations including quality agreements
Cost conscious working and optimization of processes. Ensure the efficient use of the available resources (staff, equipment, machinery, working spaces, materials).
Assistance is required in the introduction and training of new employees
Requirements:
Degree in Engineering, Chemistry, Life Science, Pharmacy or equivalent
Min. 5 years of Quality Management related experience in the Pharmaceutical industr
Experience in Qualification/Validation and CSV of Small Molecules, Analytics and/or Biologics
Sound understanding on current DI (Data Integrity) requirements
Experience with MES (Manufacturing Execution System)
Profound knowledge of global quality and GMP requirements
Karrierestufe
Management
Beschäftigungsverhältnis
Zeitarbeit
Tätigkeitsbereich
Qualitätssicherung
Branchen
Biotechnologieforschung und Arzneimittelherstellung
Mit einer Empfehlung lassen sich Ihre Chancen auf ein Vorstellungsgespräch bei Coopers Group AG verdoppeln.