Quality Executive (Technical Compliance)

Roles & Responsibilities
• Perform batch documentation review and support batch release activities for products listed on Aspire Pharma’s MIA and third-party MIAs
• Review stability data and ensure compliance with approved specifications
• Manage deviations, non-conformances, CAPAs, and change control activities
• Support MIA product setup, batch release documentation, and launch readiness activities
• Conduct monthly compliance checks and contribute to product launch activities
• Maintain up-to-date knowledge of EU/UK GxP regulations, including GMP, GDP, GVP, and GCP
• Ensure compliance with regulations related to medical devices (ISO 9001, ISO 13485, ISO 14971), controlled drugs, nutritional products, GDPR, and the UK Data Protection Act
• Communicate effectively with internal teams, vendors, and customers to implement regulatory changes
• Investigate non-conformances and deviations and support corrective and preventive actions
• Monitor vendor performance to ensure compliance and supply continuity
• Update quality procedures and documentation in line with legislative and regulatory requirements

Qualification
• Bachelor’s degree in Science or related discipline

Experience
• 5–8 years of relevant experience in Quality Assurance or Technical Compliance (desirable)
• Experience with MIA batch review and release activities (desirable)
• Strong understanding of pharmaceutical regulatory and compliance requirements

Skills
• Excellent written and spoken English communication skills
• Strong time management and organizational abilities
• High attention to detail and documentation accuracy
• Proactive team player with problem-solving mindset
• Proficiency in MS Office (Word, Excel, Outlook)
• Experience with Adobe Acrobat and electronic signature tools (desirable)
• Familiarity with Q-Pulse or other electronic QMS systems (desirable)

About the Company
Aspire Pharma is a UK-based asset-light pharmaceutical manufacturer with a diversified portfolio of over 250 products across urology, ophthalmology, CNS, dermatology, and specialty generics, delivering innovative and reliable healthcare solutions to underserved markets worldwide.