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Senior Pharmaceutical Quality Assurance Specialist
Job
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.
Responsibilities
- Serve as a quality advisor to internal teams and external partners when required
- Ensure batch documentation is ready for Qualified Person (QP) review and disposition
- Assess and approve deviations, corrective actions, and change requests
- Verify proper closure and archiving of batch records post-processing
- Join project meetings to outline and align on quality requirements
- Prepare and complete QA contributions to change controls, investigations, and CAPAs
- Review controlled documents such as procedures, protocols, forms, and reports
- Monitor and present quality performance metrics in relevant forums
- Support floor-based quality oversight during manufacturing and laboratory activities
- Mentor QA colleagues and provide training on standard quality processes
Requirements
- Bachelor's or Master's degree in Biotechnology, Life Sciences, or related field
- At least 5-10 years of experience in a QA role within a GMP-regulated environment
- Strong understanding of Quality Management Systems and regulatory compliance
- Proven experience in reviewing technical documentation and deviation handling
- Fluent English communication skills, both written and spoken
- Able to work independently, prioritize tasks, and make quality-driven decisions
- Comfortable working cross-functionally and training others in QA practices
Benefits
- Contract type: Available as either secondment (deta) or freelance (zzp)
- Region: Limburg (NL)
- Salary: Between €4,400 and €6,500 per month, based on experience
- Working hours: Full-time position with a 5-month initial term
- Environment: High-responsibility role with diverse quality tasks in a fast-paced biotech setting
- Team: Multidisciplinary team in an innovative and collaborative international workplace
- Vacancy number: 26097
IMPORTANT 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.
