Quality Assurance Officer
hace 1 día
Windsor
My client is seeking a Junior Quality Assurance & Pharmacovigilance Officer to join our Medical team. This is an excellent opportunity for a life sciences or healthcare graduate to gain hands-on experience in Quality Assurance (QA) and Pharmacovigilance (PV) within a highly regulated environment. Key Responsibilities • Support the maintenance of the Pharmaceutical Quality System and ensure ongoing compliance, • Assist with QA activities, including documentation preparation for audits and internal meetings, • Ensure alignment with local and European regulatory requirements (GDP, GMP, GVP), • Manage training records and update compliance systems (e.g. ComplianceWire), • Review and assess safety information to identify reportable cases and special situations, • Perform accurate and timely data entry into global safety databases, • Follow up on missing or incomplete safety information, • Support the development and maintenance of SOPs and work instructions, • Assist in documenting deviations, CAPAs, and data corrections, • Maintain inspection-ready records with full traceability and audit awareness Key Accountabilities • Ensure accurate, complete, and timely processing of safety cases in line with regulatory timelines, • Maintain high standards of data quality, consistency, and medical relevance, • Support internal audits and provide required documentation, • Ensure appropriate and well-documented follow-up activities, • Maintain compliance with internal procedures and regulatory expectations Key Skills • Degree in Pharmacy, Life Sciences, or a recognised healthcare discipline, • Basic understanding of QA systems and pharmacovigilance requirements (GDP, GMP, GVP), • Strong attention to detail and organisational skills, • Ability to work in a structured, process-driven environment, • Interest in regulatory compliance and patient safety, • Flexible, proactive, and eager to learn