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Key Quality Representative

Company

Unknown

Role

Key Quality Representative

Location

HAARLEM, Netherlands

Job type

Temporary

Found on Mokaru

1 week ago

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Salary

Not disclosed by employer

Job description

Your new role Reporting to the Quality Release Manager, the QA officer in Packaging plays a key role in ensuring product quality and compliance within a dynamic manufacturing environment at the Haarlem site. You will act as a key quality representative, supporting operational teams and ensuring adherence to regulatory and internal quality standards while contributing to continuous improvement and quality culture. Key Responsibilities - Support departments in implementing changes to guidelines through systems such as Veeva, VReg, and Change Control processes. - Promote and strengthen quality awareness across the production site and act as a representative for quality within multiple systems. - Participate in the introduction of new products, ensuring all quality aspects are covered - Take Quality Assurance ownership for a designated portfolio of products - Verify and approve ZERT, ZERP, and ZDSB creations - Assess and implement Quality Standards within systems such as GLIMS and SAP - Perform material control reviews and approvals in SAP - Review Certificates of Analysis (CoA), both manually and within SAP - Conduct investigations related to deviation management, when required - Write and maintain Quality Management System (QMS) procedures - Support regulatory compliance activities, including Registered Country Table management - Review and approve artwork, components Bills of Materials (BOM), and bulk BOMs. What you'll need to succeed - A Bachelor's or Master's degree in Pharmaceutical Sciences, Life Sciences, Process Engineering, Chemical Engineering, or a related field - 1-2 years of relevant experience in a quality role within a GMP-regulated environment - Experience with SAP, LIMS, and Veeva systems is advantageous - Fluency in both Dutch and English is mandatory. - Knowledge of packaging technology is a plus. - Experience with medicine registration processes is beneficial. Key Competencies - Strong attention to detail an...

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