Role DescriptionAs a Technical QA Specialist you will report to the Senior Manager QA. The technical QA team consists of 5 people within an organization consisting of 45 people. Together with the team you will keep oversight on introduction and modification of equipment, information systems and packaging configurations for commercial secondary packaging operations. By controlling the critical aspect of the operations and systems throughout the life cycle, you will be safeguarding the high quality of the medicines. Together with the team you will provide quality engineering support for quality investigations and testing strategies.
Your role will be the liaison between quality and engineering to ensure new equipment is introduced within manufacturing conforming quality quidelines. 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 on site 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
Requirements- Master degree in engineering or pharma - Minimum of 5 years experience with equipment and automation validation - 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.
- Engineering or pharma background and a high level of quality awareness - 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
Other informationThe company offers you a great opportunity to be part of our growing company, work on your own development, whilst making sure the medicines find their way to the patients who need them.
Do you have a background in engineering or pharma and a high level of quality awareness, able to manage complex projects and work closely together with a wide variety of people within the company, maintain oversight on different projects and dive into details when required?
Then become a part of this close team within a large international company and contact me!
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Helene de Vries.