About the company
An international biotechnology organization operates a large production and distribution site in the Netherlands, supplying medicines to patients worldwide. The company works in a highly regulated environment and focuses on maintaining high quality standards across all stages of the product lifecycle.
Role description
The Qualified Person is responsible for ensuring that medicinal products meet all regulatory and quality requirements before release. The role focuses on batch certification, quality oversight, and collaboration with cross-functional teams to maintain compliance. The position also contributes to quality improvements and supports regulatory documentation processes.
Key responsibilities
- Perform batch certification of medicinal products in line with regulatory requirements.
- Ensure compliance with quality standards across production, warehousing, and supply chain activities.
- Act as the quality contact for deviations and corrective actions, ensuring proper investigation and resolution.
- Review and approve quality procedures and documentation.
- Review and sign regulatory documentation related to product release.
- Collaborate with internal teams to ensure consistent quality standards.
- Support and drive continuous improvement initiatives within quality processes.
- Contribute to maintaining a high level of compliance within a regulated environment.
Requirements
- Eligible to act as a Qualified Person according to European pharmaceutical regulations.
- Master’s degree in pharmacy, life sciences, or a related scientific discipline.
- At least 2 years of experience in a Good Manufacturing Practice environment.
- Experience with batch certification or product release processes.
- Strong knowledge of pharmaceutical quality systems, including deviations and corrective actions.
- Ability to make risk-based decisions in complex environments.
- Strong communication and stakeholder management skills.
- Analytical and problem-solving mindset.
- Experience working with cross-functional teams.
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About us
Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.
SIRE Life Sciences is proud of its ability to adapt to changing trends while always maintaining the highest level of quality for both our clients and our candidates.
Our team of knowledgeable professionals provides customized staffing services to clients and candidates, including secondment, direct hire, temporary-to-hire, temporary staffing, brokering, Statement of Work and we approach each type with the same degree of professional assessment. Our refined and collaborative style is unmatched in the staffing industry. We’re able to see beyond the surface to create matches that result in successful careers for our candidates and valuable talent for our clients.
Effective employment solutions need to put the right person in the relevant place every time, using advanced systems to streamline costs and time-frames for clients.