Role DescriptionThe 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) located both in Breda and internationally.
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.
RequirementsThe job requirements: To be successful as a Technical QA Specialist you need an engineering or pharma background and a high level of quality awareness. You are able to manage complex projects and work closely together with a wide variety of people within the company. You are able to maintain oversight on different projects and dive into details when required. Working in teams and communicating effectively with all kind of stakeholders is crucial in this role.
Basic 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 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 Rutger Koning.