Headquartered in Switzerland, our client has production, R&D and business sites around the world, including Europe, North America, and Asia. Currently there are several positions available, among which the Quality Assurance Validation Manager.
• Work to identify efficiencies in the validation program approach. Work to apply lessons learned, and stay informed of industry regulatory changes as it applies to equipment / facility validation.
• Perform assigned Quality Systems activities including Document Management system, Change Control, Non Conformities, and CAPA’s.
• Present and defend the validation program and acceptance criteria to client and regulators.
• Review and revise the Validation Master Plan as necessary to ensure GMP compliance with all applicable regulations and guidelines.
• Support the Quality Engineering group to maintain the validation maintenance program.
• Train and mentor validation staff with respect to equipment and facility validation/qualification.
• Perform other duties as assigned.
• Helps others learn from experience to develop themselves
• Challenges the status quo and looks for opportunities to make improvements in his/her area of the business and beyond
• Embraces new initiatives and drives successful implementation in his/her area
• Adapts thinking and behavior to support change
• Provides feedback to his/her managers on the content of the strategy and its implementation
• Sets and delivers on individual and team objectives that support the company strategy Uses knowledge of his/her business area and related areas to make correct and timely decisions
• Works in partnership as an active member of his/her team and cross- functional working groups
• Champions and role models the values of diversity and inclusion through everyday interactions in groups or 1:1s
• Generously shares information and knowledge with others across teams and functions
• Identifies when company and customer interests may not align and seeks effective solutions to resolve or escalate
• Manages internal and external customer relations professionally and effectively
• Appropriately prioritizes multiple demands and leads defined work to successful conclusion on time
• Establishes and consistently delivers on KPIs and challenging goals for him/herself (and team)
• Ensures delivery excellence for own goals and those of his/her team
• Takes personal accountability for outcomes resulting from choices and behaviors of self and team
• Seeks and provides feedback to their team to support professional development
• Creates a positive work environment for his/her team and demonstrates high integrity
• Ensures clear and direct 2-way communication within his/her team and other organisations
• Excellent technical writing skills and the ability to document all work in a thorough, accurate and timely manner.
• Excellent written and oral communication skills and the ability to work interdepartmentally in an effective manner to carry out daily duties.
• Excellent organizational and time management skills
• Provides training and mentoring to the validation team as well as other departments as necessary to accomplish the goals of the validation program.
Robin Bisschoff +31 614795647
Robin Bisschoff +31 614795647
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