Role DescriptionPurpose of the role Monitor and maintain the quality of raw materials, finished products and packaging materials under EU GMP regulations and internal company standards.
Responsibilities1. Operational implementation of QMS (70%) - New product introduction assessment: master documentation, registrations, specifications - Change control and product variations - Formulation of risks - Validation - Preparation of Technical Transfer Protocols - Manage the (on-going) stability program: identification of packaging for sustainability testing, monitoring, reporting, drafting annual plans..
2. Support the Qualified Person (10%) - Creation of SOPs, - GMP and GDP compliance - Initiate and execute improvement processes - Completion of deviations, variations and CAPAs
3. Preparation of audits (10%)
4. Support Quality strategic business initiatives (10%) - Make proposals for efficiency enhancement - Project participation and deadlines monitoring
Requirements- Scientific background - Strong knowledge and interpretation of GMP regulations - Experience in Quality Assurance within the pharmaceutical industry (preferably in a production environment) - Advanced English skills
Other information- Type of contract: temporary via payroll (ZZP could be discussed) - Duration: until end of Q1 + anticipated extensions - Start date: ASAP (not later than 1st of December) - Location: Haarlem, The Netherlands
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Patricia Oses Equiza.