Position - Senior Quality Assurance Officer
Salary - Negotiable (depends on experience)
Location - Surrey
Are you eager to move away from the corporate giants? Do you have significant experience in quality assurance? If so, we want to connect with you!
If the idea of making a meaningful impact every day within a dynamic small business excites you, then we have the ideal opportunity for you. They champion innovation, flexibility, and a team-oriented atmosphere where your efforts are recognized and valued. Leave behind the rigidity of large corporations and join a place where you can truly thrive and grow.
We are on the lookout for an experienced Quality Assurance Officer with a stellar background in the field. Your expertise in maintaining high standards and driving continuous improvement is crucial to the company. Become a part of their team and leverage your skills to enhance quality standards. With established operations in the UK, EU, and select global markets, they offer a vibrant environment where you can excel.
Quality Assurance and Regulatory Compliance:
- Oversee and ensure adherence to UK GDP, GPPV, ISO 9001, and UK MDR, with a particular focus on WDA(H) licensed activities.
- Maintain audit readiness for GDP and ISO compliance, and host both on-site and virtual audits to ensure standards are met.
- Implement and sustain an effective Quality Management System (QMS) for the UK entity, ensuring all regulatory standards and requirements are consistently met.
- Manage all aspects of quality documentation control, including the creation, review, and revision of SOPs, policies, and quality manuals.
- Support various business functions in maintaining compliance with relevant QMS requirements.
- Conduct internal (self-inspections) and external audits (of service providers and suppliers), identifying risk areas and implementing corrective actions in response to findings.
- Lead company-wide continuous improvement initiatives within the QMS, identifying opportunities for enhancing quality and compliance processes.
- Manage non-compliance issues with the referenced standards, conducting investigations, and implementing mitigating actions.
- Present a quarterly Quality System Management overview to the Heads of Departments (HODs), highlighting areas of change, risk, opportunity, and improvement.
Global Supply Chain and Operational Management
- Execute and manage the supply chain strategy as pre-agreed by the Commercial Director, ensuring the efficient and compliant distribution of products.
- Oversee daily operations within the UK supply chain, encompassing order processing, warehousing, inventory management, and logistics.
- Manage the qualification and appointment processes for new suppliers, customers, and service providers to ensure regulatory and quality compliance.
- Develop and implement distribution, quality, and technical agreements with customers and partners, aligning them with organizational standards and regulatory requirements.
- Monitor and manage the performance of supply chain partners, ensuring adherence to agreed-upon service levels and quality standards.
- Develop and apply key performance indicators (KPIs) to measure and identify areas for improvement in operational efficiency within the distribution network.
- Collaborate with other departments to ensure distribution strategies are aligned with overall business objectives.
Leadership and Strategy Execution
- Lead company-wide training initiatives in Quality Management Systems (QMS), Good Distribution Practice (GDP) compliance, and other quality-related areas.
- Ensure staff competency and awareness of regulatory and quality standards.
- Lead risk management activities by identifying potential risks in the supply chain and quality processes and implementing appropriate risk mitigation strategies.
- Provide strategic guidance to the Board of Directors (BOD) on matters such as the appraisal of new products, the appointment of new service providers, supply chain management, the consolidation of key QMS initiatives, and hiring decisions for the quality and operations functions.
- Engage regularly with regulatory authorities such as the MHRA in the UK.
- Ensure the UK WDA(H) license remains relevant and effective according to the company's operations.
- Support and provide expertise during engagements with regulatory authorities, particularly during inspections and audits.
- Manage the budget for distribution and quality operations.
Qualification
- University degree in Pharmaceuticals or Life Sciences.
- In-depth knowledge of import and export operations.
- Knowledge and experience with WDA(H) regarding holding, procurement, and supply.
- Experience handling unlicensed medicinal products.
- Over 3 years of experience in the pharmaceutical secto and senior quality role.
- In-depth understanding of ISO 9001 requirements and GMP and GDP compliant QMS systems.
- Extensive knowledge of Human Medicines Regulations and Medical Device regulations in the UK and EU.
- Knowledge of ICH guidelines.