Computer System Validation - Senior Quality Assurance Analyst

We as QA CSV group belong to the Quality organization of Johnson & Johnson Innovative Medicine Supply Chain (IMSC) and are responsible to ensure the quality and compliance of different systems on the J&J Belgian Campus (including commercial and clinical activities in Beerse, Olen and Geel)., * Assure that all Computer System Validation related regulatory requirements are fulfilled during the complete life cycle of computerized systems (concept, project, operational and retirement phase).

• Act as Process Owner for Computer System Validation management.
• Review and approve CSV documents such as SOPs, user requirements, risks analysis's, validation plans, test scripts, changes, deviations etc) in order to maintain compliance to regulations, guidelines, J&J policies and standards.
• Maintain a current knowledge of international laws, guidelines and new evolutions related to CSV through courses, conferences, seminars, internal and external benchmarking and literature studies. Implement this knowledge to maintain and improve CSV at J&J IMSC.
• Prepare for audits and inspections by regulatory agencies, customers and internal compliance team.
• Be the spokesperson for CSV related matters during audits and inspections.
• Perform and follow up on internal and external audits to accomplish regulatory compliance.
• Cooperate with engineering, IT and other teams for the introduction of new systems and processes and for the complete life cycle of the equipment.
• Give advice and support for the preparation of CSV related activities and guard the cGMP aspects in new projects. Be a member of multi-functional teams to realize cross-departmental objectives., * Application review: We'll carefully review your CV to see how your skills and experience align with the role.
• Getting to know you: If there's a good match, you'll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.
• Staying informed: We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.
• Final steps: For successful candidates, you will need to complete country-specific checks before starting your new role. We will help guide you through these.
• Finally, at the end of the process, we'll invite you to share feedback in a short survey - your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. We're excited to learn more about you and wish you the best of luck in the process!

Do you have a Master's degree?, Have a passion for Quality, love well-functioning systems and you are eager to gain in-depth knowledge of the quality & compliance requirements in this field? Then this position is waiting for you!, * Master scientific degree or equivalent experience.

• 3 years' experience in the pharmaceutical industry.
• Knowledge of cGMP/CSV compliance (21 CFR Parts 11, 210, 211; Eudralex 4, EU Directive 2003/94/EC, EU Directive 2017/1572 and annex 11; GAMP, Data Integrity Guidelines)
• Experience with Computerized System Validation.
• Strong ownership and quality attitude. You are able to deliver on commitment timelines.
• Ability to make risk-based decisions. Understands the business implications regarding quality positions and decisions.
• Fluent in verbal and written communication in English and Dutch and are able to connect with diverse partners., Business Alignment, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Human-Centered Design, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. 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