Role DescriptionThe QA Officer is responsible for the planning and execution of daily quality assurance activities while ensuring compliance with international quality requirements as defined by the applicable guidelines (e.g. FDA, EMA, ICH) and all existing GMP standards in the area of responsibility.
Responsibilities- Planning and executing quality assurance activities (document management, batch records and label issuance, batch record review, equipment and supplier qualifications etc.) including documentation. - Monitoring compliance with all applicable GMP and safety standards. - Supporting the Qualified Person in his role, including audits and quality training. - Writing, reviewing and approving documentation (SOP’s, manufacturing and quality instructions, validation of protocols and reports, non-conformities, change requests). - Handle, distribute and archive controlled documents. - Preparing data for trending (QRB, Annual Product Review) and support internal and external audits.
Requirements- Intermediate vocational education or BSc in chemistry/biotechnology. - Knowledge of GMP is an advantage. - Good communication skills in English. - Accuracy, tidiness, self-organized, flexible, attention to detail, team player.
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.