Quality Assurance Specialist

Quality Assurance Specialist

ClinChoice

Netherlands

Main responsibilities include:

• Provide quality oversight for the AT production facility and ensure GMP compliance;
• Support GMP processes including change control, documentation, training, and inspection readiness;
• Offer QA guidance on facility/equipment design, tech transfers, validations, aseptic processing, and Annex 1;
• Review investigations, assess non-conformances, and approve CAPAs and product dispositions;
• Support and participate in risk assessments and lead GMP training initiatives;
• Promote a strong quality culture through activities such as GEMBA walks;
• Review and approve document changes and contribute to local/global quality projects;
• Optimize quality monitoring processes and tools;
• Act as QA representative during regulatory inspections and on-call support rotation;
• Partner with site teams to manage changes and mitigate compliance risks;
• Serve as a QA SME for audits, studies, and JBV (quality-related) projects.

Education and Experience:

• Bachelor’s degree or higher in Biochemistry, Biology, Pharmaceutical degree or relevant education;
• Depending on education, BSc 6 years and for MSc 4 years of experience in a GMP regulated environment (manufacturing, QA and/or QC);
• Experience in methods such as Process Excellence, Co Think or Kepner-Tregoe is recommended;
• Proven knowledge of the biotechnological/pharmaceutical industry;
• Proficiency in English both in word and in writing;
• Deep understanding and application of Global Regulatory (cGMp/ICH/FDA/EMA) guidelines in Operations environment;
• Functions independently in a complex environment to make daily judgments to balance business need, regulatory requirements, and cost efficiency for all Quality decisions. It is required to determine the level of risk, magnitude and/or complexity in order to make sound judgment on when to escalate critical issues to Quality management;
• Broad knowledge of QA systems (i.e., change control, deviation management, cGMP, validation) manufacturing and laboratory processes, facilities and utilities and technical automation;
• Problem solving and troubleshooting to initiate fresh, innovative, and compliant solutions to manage unexpected quality issues;
• Ability to drive collaboration in a fast-paced environment;
• Has good negotiation skills with a customer-oriented attitude. Influences (without formal authority) and engages colleagues throughout the site and manages diversity and conflicting viewpoints;
• Empowered professional who can make well motivated pragmatic decisions on their own.