Role DescriptionYou support the site in the development, implementation and improvement of the validation processes in accordance with cGMP norms. Your main responsibility will be to set up, execute and coordinate various validation activities. You are also the main source of expertise on the site when it comes to validation and cGMP, and the validation SME for site audits.
Responsibilities- Work closely with the Sr. Compliance Manager to develop and implement validation processes across the site; - Oversee the functional teams to ensure compliance with all documented validation policies and procedures; - Increase the level of compliance in accordance with policies from IQ, OQ, PQ and PPQ; - Monitor cGMP compliance of projects through a thorough impact assessment and ensure that critical aspects are acnhored in qualification and validation plans and protocols; - Advice and support colleagues/managers during visits and audits.
Requirements- Msc in Life Sciences; - Expertise and experience with validations in accordance with the latest industry/cGMP standards; - People management skills; - Experience with FDA regulated industries.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees Roffelsen.