Description
Responsibilities:Responsible for ensuring orderly workflow in regulated qualifications and validations of computerized systems
Actively involved in developing validation guidelines and SOPs
Contribute to user requirements and process descriptions
Develop qualification and validation plans, including risk analyses
Manage qualification environments throughout system lifecycle
Coordinate CSV measures during qualification and rollout
Ensure compliance with Data Integrity standards
Coordinate qualification and validation measures and report on progress
Collect, review, and archive qualification documents and raw data
Initiate and coordinate corrective measures as needed
Collaborate closely with various departments
Promptly inform superiors of significant deviations or events.
Requirements:
Bachelor's/Master's degree in a technical field
7+ years of experience in pharmaceuticals or related GMP environments.
Understanding of deviation and change control management, including CAPA.
Practical knowledge of quality, CSV, and system qualification.
Strong proactive and planning abilities.
Fluency in English required. Proficiency in French preferred.
Are you up for an exciting challenge? Then please apply below with an updated CV as soon as possible.