Qualified Person

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Are you an experienced Qualified Person (QP) looking to advance your career in a dynamic and fast-paced environment? We are seeking a dedicated QP to join our client’s team and ensure the highest standards in medicinal product certification and compliance. **Key Responsibilities:** – Certify medicinal product batches for sale, distribution, or clinical trials. – Ensure compliance with EU-GMP and relevant legislation. – Supervise operations to maintain legal compliance. – Coordinate with production, quality control, quality assurance, and supply chain teams. – Manage records, change controls, and subcontracted activities. – Handle GMP-related customer complaints and integrate GMP aspects into the quality management system. – Oversee risk assessments, audits, and inspections. **PPS Specific Duties:** – Ensure compliance with regulatory requirements and support the Morpeth Site Quality Review Team. – Provide QP support and guidance on Dutch Health Authorities’ requirements. – Participate in the PPS Morpeth site Quality Management Review Team and champion the Quality Agenda. **Authorities:** – Stop operations that do not comply with quality systems or legal requirements. – Release or reject raw materials and finished products. – Approve GMP suppliers and quality contracts. – Initiate recalls and inform competent authorities about product issues. **Qualifications:** – Diploma or equivalent in pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, or biology. – At least two years of practical experience in qualitative and quantitative analysis of medicinal products. – Recognized by the Dutch Health Authority (IGJ) and listed on the Manufacture and Import Authorisation. – Proficient in EU GMP regulations and experienced in operating an EU regulatory approved QMS. – Strong collaboration skills and ability to work independently. – GMP auditing knowledge and practical skills. **Skills:** – Robust technical knowledge of EU GMP and regulatory guidelines. – Highly collaborative with senior management, regulatory groups, and other stakeholders. – Ability to work under pressure in a fast-paced environment. – Good team player with a positive attitude and flexibility. **Other Requirements:** – Eligible to act as a Qualified Person under EC/2001/83 Directive. – Experience as a certifying QP for solid unit dose products, IMPs, sterile products, and narcotic products. – Minimum C1-level proficiency in Dutch and English. **Working Conditions:** – Office-based with work-from-home flexibility. – Some travel for audits within the EU and occasionally globally. – Reports to the Lead QP (NL).
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