Qualification Validation Manager (m/f/d) 100% – TEMPORARY FOR 12 MONTHS

Job Description

• Executes establishment and maintenance of Equipment Qualification System for the Operations
• Ensures proper qualification of equipment/instruments/computerized-systems and method validation/transfer/qualification/verification by guaranteeing adherence to the corresponding regulation requirements
• Acts as first contact for equipment qualification & maintenance within QA as well as equipment qualification document life cycle management and compliance issues for equipment qualification in shared systems (e.g. LIMS / CDS)
• Supervises and executes compliance activities including but not limited to releasing method validation/transfer/qualification/verification documents and to assigning GMP status and trending of equipment qualification/re-qualification in relation to supplier qualification, changes, CAPAs, audit observations, vendor change notification
• Takes care of proper qualification of GMP staff by supervising adherence to GMP trainings as well as of equipment supplier /services by supervising adherence to quality agreements
• Advises on preparation of service agreements, URS, DQ and qualification documents
• Keeps track of GMP status of equipment/instruments/ computerized systems
• Support deviations management and continuous process improvement in the area of responsibility

Requirements

• > 4 years working experience in pharmaceutical industries and GMP controlled environment preferable in Quality Control, Production or Quality Assurance
• Very good working knowledge in EU and US GMP regulations relevant for equipment qualification, maintenance, method validation/transfer and corresponding compliance systems
• Solid know-how in EU and US GMP regulations relevant for computerized systems validation
• Advanced knowledge in Data Integrity rules and requirements
• Excellent communication and decision-making skills
• Ability to provide solutions for complex challenges and work independently in a team environment
• Solution oriented, precise, and organized
• Good inter-personal skills
• Energized and open-minded
• Willingness to learn and carry out new and complex tasks
• Proactive attitude
• Excellent in German and English, French is a plus

Benefits

Our employees are very close to our hearts. At Solvias you get

• a well-structured onboarding program
• intensive training in the beginning
• the possibility for further development

Furthermore, there are a multiple range of benefits like

• flexible working time models
• 40 hours week
• at least 28.5 vacation days per year (depending on your age)
• commuter contribution for using public transport
• staff restaurant