QA Lab Supervisor
Job Description
In this role, you will be responsible for:
* Establishing and maintaining strong working relationships with partners in Quality Control (QC) laboratories, as well as with commercial and clinical Supply Chain teams
* Acting as the QA point of contact for QC laboratories, ensuring compliance with global regulations and internal quality requirements
* Supporting quality oversight of operational activities by performing QA review and approval of GMP documentation
* Managing laboratory-related deviations by:
* Supporting subject matter experts in root cause investigations
* Defining, following up, and concluding corrective and preventive actions (CAPAs)
* Evaluating trends in issue investigations and defining appropriate actions
* Approving analytical method transfers
* Ensuring that quality records (including investigations, CAPAs, change controls, and analytical method transfer protocols and reports) are handled in a timely and compliant manner by providing quality, compliance, and technical expertise to meet internal and external customer expectations
* Driving continuous improvement initiatives with a focus on quality processes by fostering innovative thinking through benchmarking and training
* Acting as a spokesperson during Health Authority inspections and customer audits
* Ensuring that deviations and complaints with potential impact on patient safety and/or product supply are properly escalated
Job Qualifications
* Master's degree in a scientific discipline with a technical specialization in analytics, chemistry, biotechnology, or equivalent experience
* 5–8 years of relevant experience in Pharmaceutical Quality Control and Quality Assurance
* In-depth knowledge of cGMP (domestic and international), ICH guidelines, and applicable policies, standards, and procedures
* Strong expertise in non-conformance handling and GMP laboratory compliance
* Strong analytical and problem-solving skills, with the ability to work flexibly under time pressure in both local and global teams
* Ability to make risk-based decisions and understand the business impact of quality-related positions and decisions
* Familiarity with analytical troubleshooting concepts and tools, applied in a results-oriented manner
* Accurate, proactive, and solution-driven mindset with strong communication skills
* Fluent in both Dutch and English (spoken and written)
S.canelas@panda-int.com
+31631501862