Qualified Person

## Opportunity Review: Qualified Person (QP) - Pharma R&D This permanent position for a **Qualified Person (QP)**, or a trainee QP close to eligibility, at **GSK in Harlow** presents a significant opportunity for ambitious quality professionals. If you are looking to elevate your career in pharmaceutical quality assurance and make a tangible impact on patient safety, this role warrants your careful consideration. ### Advantages for Aspiring Candidates: * **Direct Impact on Patient Safety:** As a QP, you will be at the forefront of ensuring that investigational medicinal products meet stringent regulatory standards. Your certification and release decisions directly contribute to the availability of safe and effective treatments, aligning with GSK's mission to "get ahead of disease together." * **Career Growth and Development:** This role offers a clear path for professional growth. Whether you are an established QP or a trainee nearing eligibility, GSK provides an environment where you can hone your expertise, expand your knowledge base, and mentor others. The opportunity to work with major dose forms and biopharmaceutical products will broaden your experience significantly. * **Cross-Functional Collaboration and Innovation:** You will collaborate with diverse teams across GSK and with external partners, fostering a culture of innovation and continuous improvement. This dynamic interaction allows for the sharing of best practices and the development of enhanced quality processes. * **Expertise in Regulatory Compliance:** A key aspect of this role is staying abreast of evolving legislative changes and assessing their impact on operations. This ensures you are continuously developing your understanding of EU and UK regulations, positioning you as an invaluable expert in the field. * **Inclusion and Excellence:** GSK emphasizes a culture of inclusion, integrity, and excellence. This means you will be joining a team that values diverse perspectives and strives for the highest standards in all its endeavors. * **Agile Working Environment:** GSK champions an agile working culture, suggesting potential for flexibility. Candidates seeking a work environment that supports adaptability will find this appealing. ### Key Considerations for Candidates: * **Eligibility and Experience:** The role requires a science degree and extensive experience in pharmaceutical manufacturing and quality operations. Crucially, candidates must be eligible to act as a Qualified Person in the UK or be imminently ready to submit for Viva. Experience with major dose forms, including tablets, aseptic sterile manufacture, and biopharmaceuticals, is highly valued. * **QP Certification of Investigational Medicinal Products:** While previous experience in QP certification of Investigational Medicinal Products is preferred, the core responsibilities will revolve around this. Candidates with a strong understanding of GMP principles and a commitment to learning will be well-positioned. * **Proactive Regulatory Acumen:** The ability to anticipate and adapt to regulatory changes is paramount. Candidates who are proactive in their approach to legislative updates and possess the skill to implement mitigation strategies will excel. * **Stakeholder Management:** Building and maintaining strong relationships with internal teams, external collaborators, and sponsors is essential. This role requires strong interpersonal skills and the ability to influence and advise effectively. * **Audit and Investigation Participation:** Involvement in audits, investigations, and quality reviews necessitates a keen eye for detail and the ability to recommend and implement corrective actions. A systematic and thorough approach is vital. This Qualified Person opportunity at GSK offers a compelling blend of scientific rigor, regulatory expertise, and impactful work. It is an excellent platform for professionals seeking to advance their careers within a leading biopharmaceutical company that is dedicated to improving global health.