Oxford Global Resources
jobid=A.0.1052
Our client, a major international player in the pharmaceutical and biotechnology industry, is seeking an experienced Senior QA Specialist to join their quality team. Operating from a dynamic site known for cell and gene therapy production, this role offers the opportunity to work at the forefront of advanced therapies within a global organisation. So if you are an experienced pharmaceutical QA officer, looking for the next step in your career, apply now! Job Description The Senior Quality Assurance Specialist plays a pivotal role in maintaining and improving quality standards across various departments. This position involves close collaboration with both internal stakeholders and, when necessary, external partners to manage quality documentation, assess deviations, and support compliance with regulatory requirements. You’ll contribute to continuous improvement by identifying risks, proposing compliant solutions, and ensuring proper documentation and timely resolution of quality issues. In addition to reviewing records and reports, the Senior QA Specialist actively participates in production oversight and leads quality initiatives, while mentoring junior QA team members. ResponsibilitiesServe as a quality advisor to internal teams and external partners when requiredEnsure batch documentation is ready for Qualified Person (QP) review and dispositionAssess and approve deviations, corrective actions, and change requestsVerify proper closure and archiving of batch records post-processingJoin project meetings to outline and align on quality requirementsPrepare and complete QA contributions to change controls, investigations, and CAPAsReview controlled documents such as procedures, protocols, forms, and reportsMonitor and present quality performance metrics in relevant forumsSupport floor-based quality oversight during manufacturing and laboratory activitiesMentor QA colleagues and provide training on standard quality processes RequirementsBachelor’s or Master’s degree in Biotechnology, Life Sciences, or related fieldAt least 5-10 years of experience in a QA role within a GMP-regulated environmentStrong understanding of Quality Management Systems and regulatory complianceProven experience in reviewing technical documentation and deviation handlingFluent English communication skills, both written and spokenAble to work independently, prioritize tasks, and make quality-driven decisionsComfortable working cross-functionally and training others in QA practices BenefitsContract type: Available as either secondment (deta) or freelance (zzp)Region: Limburg (NL)Salary: Between €4,400 and €6,500 per month, based on experienceWorking hours: Full-time position with a 5-month initial termEnvironment: High-responsibility role with diverse quality tasks in a fast-paced biotech settingTeam: Multidisciplinary team in an innovative and collaborative international workplaceVacancy number: 26097IMPORTANT NOTE: Unlimited EU working permit is required. Please do not apply if you do not have a working permit to live and work in the Netherlands. If you do not have an unlimited permit, your application will not be processed.
