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At Syner-Med, we’re a growing company driven by a passion for advancing healthcare and making a real-world impact. With a focus on key therapy areas such as Women’s Health, Vascular Medicine, and Infectious Disease, we’re committed to addressing critical medical needs and improving lives.
Collaboration and innovation are at the heart of everything we do. Our people are united by a shared purpose to deliver exceptional solutions that empower healthcare professionals and create meaningful change for patients.
If you’re looking to grow in a dynamic, fast-paced environment where creativity, integrity, and collaboration are valued, Syner-Med is the place for you. Here, you’ll have the opportunity to make a difference in the world while advancing your career in one of the most impactful industries.
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Office Location: Reigate, Surrey
We are seeking a dedicated Quality Assurance Officer to join our team, reporting directly to the Commercial Director. In this role, you will oversee Syner-Med's compliance with GMP and GDP standards, manage the Quality Management System (QMS), and ensure strict adherence to quality standards and regulatory requirements for pharmaceutical products and medical devices. You will be responsible for driving all aspects of quality assurance in alignment with cGMP and cGDP practices. This is a key position for maintaining the highest standards of quality, safety, and compliance across our operations.
Responsibilities
Quality Assurance and Regulatory Compliance:
1. Oversee and ensure adherence to UK GDP, GPPV, ISO 9001, UK MDR, particularly focusing on WDA(H) licensed activities.
2. Always ensure audit readiness for GDP and ISO compliance, and host on-site and virtual audits for such.
3. Implement and maintain an effective QMS for the UK entity ensuring that all regulatory standards and requirements are met.
4. Manage all aspects of Quality documentation control, including creation, review, and revision of SOPs, policies, and quality manuals.
5. Support other business functions in ensuring compliance with relevant QMS requirements.
6. Conduct internal (self-inspections) and external (of service providers and suppliers) audits, ensuring risk areas are identified and corrective actions are implemented in response to findings.
7. Drive company-wide continuous improvement initiatives within the QMS, identifying opportunities for enhancing quality and compliance processes.
8. Manage non-compliance with the above referenced standards, investigate and implement mitigating actions.
9. Present a Quarterly Quality System Management overview to the HODs, highlighting areas of changes, risk, opportunity, and improvement.
Global Supply Chain and Operational Management
1. Execute and manage the pre-agreed (by Commercial Director) supply chain strategy, ensuring efficient and compliant distribution of products.
2. Oversee day-to-day operations in the UK supply chain, including order processing, warehousing, inventory management, and logistics.
3. Manage new supplier, customer and service provider qualification and appointment processes to ensure regulatory and quality compliance.
4. Develop and implement distribution, quality and technical agreements with customers and partners, aligning them with organisational standards and regulatory requirements.
5. Monitor and manage the performance of supply chain partners, ensuring adherence to agreed service levels and quality standards.
6. Develop and apply KPIs to measure and identify areas for improvement in the operational efficiency in the distribution network.
7. Collaborate with other departments to align distribution strategies with overall business objectives.
Leadership and strategy execution:
1. Lead company wide training initiatives in QMS, and GDP compliance, and other quality-related areas.
2. Ensure staff competency and awareness of regulatory and quality standards.
3. Lead risk management activities, identifying potential risks in the supply chain and quality processes, and implementing appropriate risk mitigation strategies.
4. Provide strategic guidance to the BOD on subject matters such as appraisal of new products, appointment of new service providers, supply chain management, consolidation of key QMS initiatives and hiring decisions on behalf of the quality and operations functions.
5. Engage regularly with regulatory authorities such as the MHRA in the UK.
6. Ensure UK WDA(H) license remains relevant and effective according to the operations carried out by the company.
7. Support and provide expertise during engagements with regulatory authorities, particularly during inspections and audits.
8. Manage the budget for distribution and quality operations.
Qualifications
The qualifications for a Quality Assurance Officer are:
1. University Degree in Pharmaceuticals or Life Sciences.
2. In-depth knowledge of Import and Export operations
3. WDA(H) knowledge and experience on holding, procurement, and supply
4. Experience in handling Unlicensed medicinal products
5. 3+ years of pharmaceutical sector experience
6. 2+ years of experience in a senior Quality role
7. In depth understanding of ISO 9001 requirements and GMP and GDP compliant QMS systems
8. In depth knowledge of Human Medicines Regulations and Medical Device regulations in the UK and EU.
9. Knowledge of ICH guidelines
💼 Your next big step starts here. Apply today and become part of a team that’s changing lives—one breakthrough at a time.
We aim to review all applications and provide a response within 2 weeks. If you do not hear from us during this time, unfortunately, it means your application has not been successful.