QA Compliance Officer
hace 4 días
Scotland
About the Role A leading pharmaceutical development and manufacturing organisation is seeking a QA Compliance Officer to support the governance and compliance of its Pharmaceutical Quality Management System (PQS). This role plays a key part in maintaining regulatory compliance across international standards including UK/EU/US GMP/GDP and ICH guidelines. Key Responsibilities • Support quality system elements such as QMS monitoring, supplier qualification, and audits., • Assist in maintaining and updating regulatory registrations, licences, and certifications., • Track site compliance commitments and regulatory trends., • Collaborate with site functions to reduce compliance issues and implement improvements., • Review QMS documentation in line with global regulatory guidance., • Lead Quality Management Review meetings., • Support investigations and develop effective CAPA., • Prepare for regulatory and customer audits and support follow-up., • Escalate significant compliance concerns to Quality Management., • Build strong working relationships with stakeholders. Essential Qualifications & Experience • Degree or relevant qualification in a scientific, business, or engineering discipline., • Minimum 2 years’ experience in QA within a GMP environment., • Experience conducting internal or supplier audits., • Experience with QMS documentation (SOPs, deviations, investigations, CAPA). Desirable Experience • Certified Auditor training., • Supplier/vendor/material approval experience., • Experience supporting regulatory audits. Key Competencies • Strong attention to detail, • Problem-solving skills, • Excellent communication, • Proficiency in Microsoft Office applications What is on Offer • Excellent benefits package including enhanced pension, healthcare and bonus scheme., • Development and learning opportunities.