Qualification Validation Manager

Job Description

The Qualification Validation Manager establishes and maintains the equipment qualification system for the operation of the facility.

Critical Performance Areas:

• 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, …)

Essential Job Functions:

• 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 qualifications, changes, CAPAs, audit observations, and vendor change notifications
• 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

• At least 4 years’ working experience in pharmaceutical industries and GMP controlled environments, preferably 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
• Excellent communication and decision-making skills
• Ability to provide solutions for complex challenges and work independently in a team environment

Other Desired Skills/Abilities

• Solution oriented, precise and organized
• Good inter-personal skills and proactive attitude
• Energized, open-minded, and willing to learn and carry out new and complex tasks
• Excellent, open-minded, and willing to learn and carry out new and complex tasks

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