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Quality Assurance Validation Manager – Geleen

Function

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.



Requirements

Agile

• 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


Business Acumen

• 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


Collaboration

• 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


Customer Focus

• 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


Driving Results

• 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


Leadership

• 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


Skills

• 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.

Information

Robin Bisschoff +31 614795647

Application

Robin Bisschoff +31 614795647

By |October 7th, 2019|Vacancies|0 Comments

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