Join Syner-Med: Where Innovation Meets Impact &##127775;
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.
Explore opportunities with Syner-Med and help shape the future of healthcare.
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.
Quality Assurance and Regulatory Compliance:
# Always ensure audit readiness for GDP and ISO compliance, and host on-site and virtual audits for such.
# Implement and maintain an effective QMS for the UK entity ensuring that all regulatory standards and requirements are met.
# Manage all aspects of Quality documentation control, including creation, review, and revision of SOPs, policies, and quality manuals.
# 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.
# Drive company-wide continuous improvement initiatives within the QMS, identifying opportunities for enhancing quality and compliance processes.
# Present a Quarterly Quality System Management overview to the HODs, highlighting areas of changes, risk, opportunity, and improvement.
Execute and manage the pre-agreed (by Commercial Director) supply chain strategy, ensuring efficient and compliant distribution of products.
# Oversee day-to-day operations in the UK supply chain, including order processing, warehousing, inventory management, and logistics.
# Manage new supplier, customer and service provider qualification and appointment processes to ensure regulatory and quality compliance.
# Develop and implement distribution, quality and technical agreements with customers and partners, aligning them with organisational standards and regulatory requirements.
# Monitor and manage the performance of supply chain partners, ensuring adherence to agreed service levels and quality standards.
# Develop and apply KPIs to measure and identify areas for improvement in the operational efficiency in the distribution network.
# Lead company wide training initiatives in QMS, and GDP compliance, and other quality-related areas.
# Ensure staff competency and awareness of regulatory and quality standards.
# Lead risk management activities, identifying potential risks in the supply chain and quality processes, and implementing appropriate risk mitigation strategies.
# 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.
# Engage regularly with regulatory authorities such as the MHRA in the UK.
# Support and provide expertise during engagements with regulatory authorities, particularly during inspections and audits.
# Manage the budget for distribution and quality operations.
The qualifications for a Quality Assurance Officer are:
# University Degree in Pharmaceuticals or Life Sciences.
# 3+ years of pharmaceutical sector experience
#2+ years of experience in a senior Quality role
# In depth knowledge of Human Medicines Regulations and Medical Device regulations in the UK and EU.
# Apply today and become part of a team that’s changing lives—one breakthrough at a time.