Performs testing of samples linked to operations, validation, utilities and environmental monitoring samples
Coordinate and work on the transfer, development and validation of analytical methods including qualification of equipment needed for analysis
Coordination in maintenance, calibration and use of laboratory equipment
Actively contribute to the GMP Inspection Readiness of QC to ensure the fully compliance of relevant Quality System and Procedural documents
Actively contribute to the QC operational readiness managing projects (external and internal) and the assigned to ressources (including coordination of people daily tasks)
Participates in the transfer, development and validation of analytical methods including qualification of equipment needed for analysis
Creation and revision of guidance documents such as SOPs/ WIs and other related documents
Profile
Master-s degree or higher in Life Sciences, Chemistry, Biochemistry, or a related scientific field (lower educational background acceptable with relevant experience)
Solid experience in chemical or biochemical laboratories, including work in a regulated GMP environment
Experience performing analytical testing of samples related to operations, validation, utilities, and environmental monitoring
Strong expertise in analytical method transfer, development, and validation
Experience with qualification, maintenance, and calibration of analytical laboratory equipment
Solid understanding of GMP regulations, quality systems, and inspection readiness within QC laboratories
Experience in creating and revising SOPs, work instructions, and other quality documentation
Ability to coordinate QC activities and support operational readiness projects in laboratory environments
Strong collaboration and communication skills, working effectively across cross functional teams
Demonstrated ability to drive results, adapt quickly to changing situations, and maintain a strong business and quality focus