About this role
- Non-Conformance Specialist Vacancy number : A-2-2600067 Johnson & Johnson Innovative Medicine - Leiden (Nederland) For our client, Johnson & Johnson Innovative Medicine , we are looking for a Non-Conformance Specialist . Keywords - Non-Conformance Management - GMP Compliance - Root Cause Analysis - Quality Control - Separation techniques (HPLC) Profile As Non-Conformance (NC) Specialist within the Separations QC department at Janssen Biologics, you are responsible for performing, documenting, and managing non-conformances in accordance with GMP and regulatory requirements. You lead investigations related to testing of raw materials, in-process materials, drug substances and drug products, and conduct root cause analyses using structured tools such as Fishbone, 5 Whys and KT analysis. Based on your findings, you define, coordinate and implement corrections, corrective and preventive actions (CAPAs) and effectiveness checks. You assess the potential product quality and compliance impact of non-conformances and provide recommendations on product disposition. You maintain accurate and well-organized records for internal and external audits and inspections, and act as SME during these activities. You work closely with cross-functional teams including Quality Assurance, Manufacturing, PQM, DPDS and Regulatory Affairs to resolve quality issues and ensure compliance with FDA, EMA, ICH and cGMP guidelines. - Monitor and analyse trends in non-conformances and contribute to periodic trend reports (e.g. OOS/OOT). - Contribute to training programmes related to non-conformance management for internal staff. - Support continuous improvement initiatives and help optimise quality systems and workflows. Who we're looking for You hold a Bachelor's or Master's degree in Chemistry, Biology, Pharmaceutical Sciences or a related scientific discipline. An advanced degree or certification such as Six Sigma or ISP is a plus. You bring a minimum of 3 ...