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Quality & Compliance Specialist

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Haarlem, Noord-Holland, NL

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Haarlem, Noord-Holland, NL
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Company Our client is a leading organisation in the pharmaceutical manufacturing sector. They operate in a highly regulated environment and are committed to delivering safe, high-quality products through strong quality standards, continuous improvement, and a culture where compliance and collaboration are key. Job Description We are looking for a Quality & Compliance Specialist to support day-to-day production by ensuring activities are performed in line with GMP requirements and internal quality standards.

The role focuses on deviation support, investigations, CAPA follow-up, and strengthening documentation practices across manufacturing and packaging operations. Responsibilities - Support manufacturing and packaging teams with deviations and quality-related questions. - Assess deviations and advise whether production activities should be paused or stopped when needed. - Monitor production processes and identify deviations from established procedures.

- Investigate and document deviations and complaints, ensuring clear, compliant records. - Perform and document root cause investigations and drive CAPA actions to closure. - Propose and support improvements to production methods, processes, and product quality. - Contribute to continuous improvement initiatives, including actions from internal/external audits. - Review and support updates to SOPs, batch manufacturing records, and related documentation.

- Ensure quality standards and GMP instructions are implemented and maintained in the production environment. - Support compliance investigations and audit responses where required. - Provide knowledge transfer and deliver training to relevant stakeholders. - Participate in operational and quality meetings with key internal stakeholders. Requirements - Academic working and thinking level (Master’s level or equivalent), preferably in Pharmacy, Chemical Engineering, or a related field.

- Experience within the pharmaceutical industry, ideally in or closely supporting a production environment. - Strong knowledge of quality assurance systems and GMP documentation practices. - Experience with deviation management, investigations, root cause analysis, and CAPA. - Strong communication skills with an advisory, stakeholder-focused approach. - Good written and spoken English. - Able to work effectively in a dynamic environment with shifting priorities.

- Temporary Full-Time Contract (3 Months Duration) Other Information This position is based on-site in Haarlem, Netherlands. The selected candidate will work closely with a range of internal stakeholders across production, quality, and technical teams and will play a key role in maintaining compliance and driving improvement. If you are interested and want to apply, please submit your application via the apply button below and contact me.

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