Role DescriptionAs Technical QA Specialist you will report to the Senior Manager QA. The technical QA team consists of 5 people and is part of the Breda QA organization of 45 people. The technical QA group keeps oversight on introduction and modification of equipment, information systems and packaging configurations for commercial secondary packaging operations.
ResponsibilitiesYour responsibilities as Technical QA Specialist are:
- 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.
RequirementsInteresting in the job? The requirements are:
- 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.
Other informationOur client offers you a great opportunity to be part of their growing company, work on your own development, whilst making sure our medicines find their way to the patients who need them.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Diana Prieto Reyes.