Descripción de la oferta
pbQuality Control Supervisor – Stabilities /b /ppbLocation: Girona | Full-time | Pharmaceutical Manufacturing /b /ppbr/ppWe 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. /ppbr/ppThis 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. /ppbr/ppbThe Role /b /ppYou will play a key role in planning, supervising and reviewing stability studies and analytical validation activities, while overseeing day-to-day QC laboratory operations. /ppbr/ppKey responsibilities include: /pulliEstablishing and managing stability study plans and analytical method validation activities /liliSupervising and coordinating QC laboratory operations related to stability programmes /liliReviewing protocols, technical reports and regulatory documentation linked to stability and validation /liliMonitoring study timelines, identifying risks and ensuring on-time delivery of results /liliActing as a key interface between QC and Regulatory Affairs to support registration and submission activities /liliPerforming data checks and ensuring accuracy of stability testing results /liliManaging deviations, investigations and CAPAs within the QC environment /liliEnsuring all activities are carried out in compliance with GMP and quality standards /liliSupporting audits and regulatory inspections /liliDriving continuous improvement in laboratory processes, efficiency and compliance /li /ulpbr/ppbYour Profile /b /ppWe’re looking for someone with strong experience in QC within a GMP environment, with particular exposure to stability studies and analytical method validation. /ppbr/ppYou will likely have: /pulliExperience working in a GMP-regulated QC laboratory /liliHands-on involvement in stability studies (ICH) and/or analytical method validation /liliExperience reviewing technical documentation, protocols and reports /liliExposure to deviations, investigations and CAPAs /liliExperience supervising, coordinating or mentoring laboratory teams /liliStrong understanding of analytical techniques (e.g. HPLC, ELISA, microbiology or similar) /liliFamiliarity with systems such as LIMS, Trackwise or similar /li /ulpbr/ppbWhy Apply /b /pulliHigh-impact role with ownership of stability programmes and validation activities /liliOpportunity to step into or develop leadership responsibilities /liliStrong exposure to Regulatory Affairs and product lifecycle activities /liliCollaborative GMP environment with cross-functional visibility /li /ul
