Qualified Person (QP)
3 days ago
Vourey
Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia, and the Americas. Position Overview Due to our constant growth, we are currently looking for a full-time Qualified Person (QP) with over 10 years of experience fitting the following mandatory skill-set and willing to work in Vourey, France. The successful candidate will ensure compliance with Good Manufacturing Practices (GMP) and regulatory requirements (EU GMP, FDA, etc.). The QP will be responsible for batch certification, quality oversight, and regulatory compliance in a pharmaceutical manufacturing or contract testing/production environment. Key Responsibilities • Review and certify batches of medicinal products for release in compliance with EU GMP Annex 16 and other regulatory requirements., • Ensure all manufacturing, testing, and distribution activities comply with GMP, company procedures, and regulatory standards (EMA, FDA, MHRA, etc.)., • Lead or support internal/external audits, regulatory inspections, and follow-up on corrective actions (CAPA)., • Approve manufacturing, packaging, and testing documentation to ensure compliance., • Oversee quality investigations, deviations, and out-of-specification (OOS) results, ensuring timely resolution., • Drive quality improvement initiatives and risk management activities., • Provide GMP training to relevant departments. Qualifications o Master’s degree in Pharmacy, Chemistry, or Life Sciences (required for QP eligibility per EU Directive 2001/83/EC). o Minimum 10 years in pharmaceutical quality assurance/control in a GMP environment. o Proven experience as a QP with batch release responsibilities. o Strong knowledge of EU GMP, FDA CFR 210/211, ICH guidelines. o Eligible to act as a QP in the EU (listed on the national QP register). o Proficiency in regulatory compliance, risk assessment, and quality systems. o Experience with EMEA/FDA inspections and audits. o Fluency in French. o Excellent analytical and problem-solving skills. o Strong communication and leadership abilities. Preferred Qualifications · Experience in sterile manufacturing environments, biologics, or ATMPs (Advanced Therapy Medicinal Products). · Knowledge of PIC/S, WHO-GMP, or other international regulations. · Experience with ERP/MES systems (e.g., SAP, TrackWise). Next Steps Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial Talent Acquisition interview. If there's a positive match, a technical interview with the Hiring Manager will be arranged. In the case of a positive feedback coming from the Hiring Manager interview, the recruiter will contact you for the next steps or to discuss our proposal. Alternatively, if the feedback is negative, we will contact you to halt the recruitment process. Working at PQE Group As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world. If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you. Apply now and take the first step towards an amazing future with us.
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