Vacature QA Automation Specialist

QA Automation specialist

• Quality
• Quality Assurance
• Analyst, Quality Assurance (P4 - N23)
• Leiden, South Holland, Netherlands
• 5 24 2024
• 24W

Job Description
The QA department is going digital and is in need for a QA Automation Specialist. Are you the automation specialist that brings QA to the next level of automation? Are you a pioneer and ready to build on a new QA automation team? We are looking for an QA Automation Specialist who has demonstrable experience with computerized systems in a GxP environment.
As an QA Automation Specialist, you will act as a domain Expert for relevant automation systems. You are responsible for the configuration of local owned automation systems and act as point of contact for global owned automation systems. Local owned automation systems include SmartQA, different QA Reporting tools (based on R-Shiny), Raw Materials Release tool, and different Tableau Dashboards. Example of global automation systems are SAP, MES, TrackWise, Comet and eLIMS.
As an QA Automation Specialist, you will participate in local and global initiatives for new and updated automation tools. You will support the QA team in translating the user requirements from the end-user to the IT department. You will take the lead in the design and execution of User Acceptance Testing, following the Software Development Life Cycle Procedures.
The activities are very dynamic and varied. The candidate loves challenges, doesn't avoid problems, and enjoys working in various teams.
About the Company: J&J Innovative Medicine / Supply Chain (Janssen Biologics BV) is a multinational pharmaceutical company that has been for more than 25 years a leader in the field of biomedicines. Through the dynamic science of biotechnology, we continue to seek innovative ways to treat cancer, infectious diseases, cardiovascular and metabolic diseases, and immune-mediated inflammatory disorders (I.M.I.D.s), such as rheumatoid arthritis and psoriasis.
The department Quality Assurance sees to that quality systems are applied as per GMP standards within J&J Innovative and is responsible for handling non-conformances, bulk (PFB / FB) and intermediate (DPC / CSS) release and change control. The QA department plays a meaningful role in providing advice on quality topics to all departments of the supply chain.
Tasks and responsibilities
• Responsible for the maintenance and updates of local owned automation systems in accordance with the detailed specifications.
• Responsible for the technical implementation of new systems within the organization in collaboration with other teams.
• Responsible for documenting administrator procedures, technical installation procedures and maintenance procedures.
• Provide support in case of (computerized) problems.
• Takes part in local automation initiatives and projects, in collaboration with the global organization and in alignment with business needs.
• Responsible for User Acceptance Testing for new and updated automation systems.
• Responsible for creating and maintaining departmental Dashboards.

Requirements
• Bachelor's degree (HBO) in Life Sciences or Computer Sciences or highly experienced in a similar position.
• Minimal 2 years of work experience in Pharma with GMP and automation skills.
• Experience with (Computer) System Validation in a GxP environment.
• Experience in QA processes is a plus.
• Programming experience is a requirement.
• Experience with GAMP5 and 21CFR Part 11 is desirable.
• Affinity with structured data (SQL) is considered as desirable.
• Ability to engage with personnel at all levels within the organization, to build and maintain fruitful relationships.
• You have shown skill in English both in word and in writing.
• Planning skills, ability to prioritize multiple commitments.
• Problem solving and analytical capability - ability to prove trouble shooting expertise;
• Pro-active, works independently, takes actions in the absence of specific instructions, and can write protocols/reports, business correspondence and procedures.
This is what awaits YOU at J&J: This is an opportunity to work with a highly motivated team and to be a member of a Johnson & Johnson company, with an excellent record in employee continuous professional development and business improvement. At Johnson & Johnson our culture enables dynamic and impactful careers.
Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

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