Descripción de la oferta
Quality Control Supervisor – Stabilities
Location: Girona | Full-time | Pharmaceutical Manufacturing
Asegúrese de leer la descripción completa a continuación y, si confía en que cumple todos los requisitos, envíe su solicitud de inmediato.
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
xqysrnh
- 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
