Role DescriptionWithin this position you will work in a QA team of 5 persons and be the liaison between the quality and engineering. In this role you need to ensure new equipment is introduced within manufacturing conforming guidelines. The team keeps oversight on introduction and modification of equipment, information systems and packaging configurations for commercial secondary packaging operations. By controlling the critical aspect of our operations and systems throughout the life cycle, they safeguard the high quality of the medicines. Additionally, they provide quality engineering support for quality investigations and testing strategies.
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.
Requirements- Master degree in engineering or pharma; - At least 5 years of professional experience within a GMP environment - Relevant experience with equipment and automation validation - Knowledge of the Quality Assurance principles - Able to work in complex projects - Able to communicate with all kind of stakeholders
Other informationWe offer you a great opportunity to be part of the growing company, work on your own development, whilst making sure our medicines find their way to the patients who need them. Sounds interesting?
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Ria Bos.