Senior Pharmaceutical Specialist

Job Description

Would you like to use your expertise to contribute to a healthier world? As part of our innovative team in Haarlem, you will work alongside colleagues to ensure the safe packaging and distribution of medicines and vaccines to more than 140 countries worldwide.

For our Centre of Excellence Quality team in Haarlem, we are looking for a Senior Pharmaceutical Specialist. Are you passionate about quality, collaboration, and continuous improvement? If so, we would love to hear from you.

At our pharmaceutical manufacturing site, quality, compliance, and scientific excellence are at the heart of everything we do. As part of the Centre of Excellence Quality, you will join a collaborative and quality-driven team that supports the site's core activities of device assembly, packaging operations, process improvements and technology transfers in a highly regulated GMP setting.

We are looking for a Pharmaceutical Specialist who combines strong technical expertise with a practical, solution-oriented mindset. In this role, you will work closely with production, quality, technical operations and local and global cross-functional stakeholders to ensure that product quality risks are effectively managed and that our processes remain compliant, robust and continuously improving.

As Pharmaceutical Specialist, you provide expert guidance on pharmaceutical and technical topics related to device assembly, packaging processes, equipment, process changes and technology transfers. You advise IPT and Centre of Excellence leadership and teams, help resolve complex product quality issues and ensure that processes, documentation and risk assessments meet applicable GMP, regulatory and company standards.

You will play an important role in maintaining process control, supporting inspections and audits, driving continuous improvement, and strengthening a culture of quality, compliance, safety, and collaboration.

• →Advise IPT and Centre of Excellence leadership and teams on pharmaceutical and technical aspects of device assembly, packaging equipment, process changes and technology transfers.

• →Identify, assess and manage product quality risks in line with GMP, regulatory requirements, industry standards and company procedures.

• →Evaluate external guidelines and translate them into relevant pharmaceutical policies, procedures and working practices.

• →Author, review and approve GMP documentation, including documentation related to process control, investigations, changes and continuous process verification.

• →Lead or contribute to the resolution of complex technical and product quality issues, using pharmaceutical expertise, data review and trend analysis.

• →Facilitate, lead or participate in Quality Risk Assessments and ensure appropriate risk mitigation and control measures are implemented.

• →Monitor compliance within the IPT or Centre of Excellence and initiate corrective and preventive actions where needed.

• →Support GMP inspections and ISO 13485 audits in collaboration with other site and global functions.

• →Drive continuous improvement initiatives, technical projects and change control activities in a regulated environment.

• →Contribute to training program development and help foster a high-performing, quality-focused and collaborative team culture.

• Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Chemical Engineering or a related scientific or technical discipline.

• 3–5 years' experience in pharmaceutical manufacturing, preferably within device assembly, packaging operations, equipment, process technology transfer or design transfer.

• Experience working in a GMP-regulated environment; experience with ISO 13485 is considered an advantage.

• Strong knowledge of quality assurance, GMP compliance, regulatory requirements, industry standards and quality management systems.

• Experience with technical investigations, change control, quality risk assessments and continuous improvement initiatives.

• Ability to analyze complex technical and quality-related issues and translate findings into practical recommendations.

• Strong communication and advisory skills, with the ability to engage effectively with cross-functional teams and leadership.

• Conversational Dutch language skills.

• Collaborative mindset with the ability to motivate others and contribute to a high-performance, quality-focused culture.

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