Role DescriptionIn this role you will report to the Senior QA Manager and be part of the technical QA team. This team consists of 5 people and is part of the QA organization of 45 people. They keep oversight on introduction and modification of equipment, systems and operations. By controlling the critical aspect of our operations and systems throughout the life cycle, we safeguard the high quality of our medicines. Additionally, we provide quality engineering support for quality investigations and testing strategies.
The Technical QA Specialist will be the liaison between quality and engineering to ensure new equipment is introduced within manufacturing conforming quality guidelines. You will work closely together in different project teams with the following departments: Process Development (PD), Maintenance and Engineering (M&E), Production, Information Systems (IS).
Responsibilities- Agree on the validation strategy and provide guidance regarding design, characterization and validation for equipment and information systems in cooperation with the other departments; - Assure agreed validation strategy is properly documented and aligned with procedural and regulatory requirements by reviewing and approving validation documentation; - Provide support to Plant QA regarding equipment or information system related production issues. You provide quality engineering support to establish appropriate sampling plans and acceptance criteria; - Project team member to develop efficient quality processes and translate them in standard operating procedures; - Perform final review of technical change controls, confirming assessments of different stakeholders are complete and all tasks are correctly represented in the record.
RequirementsMaster degree in engineering or pharma; At least 4 years of professional experience within a GMP environment; Relevant experience with equipment and automation validation; Knowledge of the Quality Assurance principles; Able to work on a wide variety of projects simultaneously; Able to work in a changing environment; Fluent in English.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Laura Hoekstra.