Quality Control Supervisor
hace 16 horas
Girona
Quality Control Supervisor – Stabilities Location: Girona | Full-time | Pharmaceutical Manufacturing We are supporting a pharmaceutical organisation in the Girona area looking to appoint a Quality Control Supervisor – Stabilities to take ownership of stability studies and analytical method validation within a GMP-regulated environment. This is a hands-on role focused on coordinating stability programmes, ensuring compliance, and working closely with Regulatory Affairs and cross-functional teams to support product lifecycle and registration activities. The Role You will play a key role in planning, supervising and reviewing stability studies and analytical validation activities, while overseeing day-to-day QC laboratory operations. Key responsibilities include: • Establishing and managing stability study plans and analytical method validation activities, • Supervising and coordinating QC laboratory operations related to stability programmes, • Reviewing protocols, technical reports and regulatory documentation linked to stability and validation, • Monitoring study timelines, identifying risks and ensuring on-time delivery of results, • Acting as a key interface between QC and Regulatory Affairs to support registration and submission activities, • Performing data checks and ensuring accuracy of stability testing results, • Managing deviations, investigations and CAPAs within the QC environment, • Ensuring all activities are carried out in compliance with GMP and quality standards, • Supporting audits and regulatory inspections, • Driving continuous improvement in laboratory processes, efficiency and compliance Your Profile We’re looking for someone with strong experience in QC within a GMP environment, with particular exposure to stability studies and analytical method validation. You will likely have: • Experience working in a GMP-regulated QC laboratory, • Hands-on involvement in stability studies (ICH) and/or analytical method validation, • Experience reviewing technical documentation, protocols and reports, • Exposure to deviations, investigations and CAPAs, • Experience supervising, coordinating or mentoring laboratory teams, • Strong understanding of analytical techniques (e.g. HPLC, ELISA, microbiology or similar), • Familiarity with systems such as LIMS, Trackwise or similar Why Apply • High-impact role with ownership of stability programmes and validation activities, • Opportunity to step into or develop leadership responsibilities, • Strong exposure to Regulatory Affairs and product lifecycle activities, • Collaborative GMP environment with cross-functional visibility