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Qualified Person
2 months ago
We are seeking a highly skilled and experienced Qualified Person to join our Quality Assurance team at GlaxoSmithKline. As a Qualified Person, you will play a critical role in ensuring the quality and compliance of our pharmaceutical products.
Key Responsibilities- Quality Assurance and Compliance: Provide Qualified Person certification and perform quality oversight of GMP functions, including batch-release for manufactured product for clinical trial purposes.
- Regulatory Compliance: Ensure compliant operations are in place to allow for UK certification of batches of Investigational Medicinal Products and assure products meet regulatory requirements.
- Legislative Knowledge: Maintain knowledge of legislation changes applicable to QP Certification, including evaluating impact and proposing mitigation for compliant management and/or introduction.
- Collaboration and Communication: Provide QP advice to GSK project teams, external collaboration partners, and sponsors concerning acquisitions and unlicensed medicines to reduce regulatory risk to GSK and ensure information and other QP assurances are obtained.
- Relationship Building: Build and maintain internal and external business relationships, communicating and interacting at various levels internally and externally.
- Audit and Investigation: Participate in audits/investigations (e.g., Quality Investigations, customer complaints, and vendor complaints) and recommend corrective and preventative actions.
You will be a Qualified Person (QP) on a UK-licence, with strong experience of working in quality at a sophisticated manufacturing site. You will be self-motivated, resilient, and calm, with strong communication skills.
About GlaxoSmithKlineGlaxoSmithKline is a global biopharma company with a special purpose - to unite science, technology, and talent to get ahead of disease together. We prevent and treat disease with vaccines, specialty, and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology, and oncology).
What We Offer- Competitive Salary
- Annual Bonus based on company performance
- Opportunities for Professional Development
- Hybrid Working within GSK policies
- Employee Recognition Programs
