Senior Commercial Quality Specialist & Qualified Person SK

Senior Commercial Quality Specialist & Qualified Person SK is based in Bratislava, Slovakia.

Regime: Full time

What You Will Do:

You will support Commercial Quality Manager to deploy, maintain and improve the cluster Quality Management System (QMS).Assure compliance with local Slovak legislation, especially Good Distribution Practice (GDP)for OTC products. You will provide support for QA relevant processes in the other cluster countries as defined in the CE CQ Roles & Responsibilities matrix.

Key Responsibilities

• Support in EMEA, CE and CEE CQ projects in order to keep high level of or improve GxP compliance as well as Excellence in Execution
• Ensure that all legal requirements are respected, particularly the Cluster and country specific ones applicable for all activities/processes and products in the Marketing Company
• Initiation of non-conformances (INV) and change controls (GCC)
• Conduct internal and external audits (supplier, distributor) following the CE audit program and ensure necessary CAPA´s are implemented
• Initiation of QA training for new employees
• Maintain Artwork overview for release needs and share with the warehouse and ensure the data are up to date
• Supervise non-product related Change Control management in Slovak Republic
• Record any quality issues related to product and GDP into company INV&CAPA systems and manage the ones related to GDP in Slovakia
• Coordinate and perform the administrative release of OTC products in the local warehouse/crossdock according to local requirements and SOP
• Report deliveries and consumptions of OTC products to HA according to local requirements
• Perform 3PL Inspection once per year and have an oversight on delegated actions
• Perform W2W in the warehouse every year
• Ensure self-inspection is performed every year

What We Are Looking For:

Required Qualifications

• University degree in Pharmaceutics
• A minimum of 4+ years of experience in quality and as qualified person
• Knowledge and experience with quality systems
• Experience in production, Quality or RA or medicinal products, cosmetics, food supplements, medical devices or equivalent
• Knowledge and experience in working in GDP and/or GMP environment
• Knowledge of Microsoft Office software: Excel, Word, PowerPoint, Acrobat
• Advanced level of English and Slovak

What’s In It For You:

• Competitive Benefit Package
• Paid Company Holidays, Paid Vacation, Volunteer Time & More!
• Learning & Development Opportunities

Kenvue is proud to be an Equal Opportunity Employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.