Hemel Hempstead, England, United Kingdom
• 13-month student placement followed by a graduate position as a Good Manufacturing Practice (GMP) Auditor in the Development Quality Department at MSD. This role involves approving the release of supplies for over 25 programmes and 100 protocols that are part of global clinical trials. • The role also involves the review of regulatory filings, certificates of analysis and product specifications to ensure compliance with guidelines for the release of clinical supplies. Additional experience includes the review of batch records, change controls and deviations. This requires strong analytical skills and constant attention to detail. • Any discrepancies identified are resolved through collaboration with other departments in the UK and overseas, requiring diplomacy and strong communication skills. • Prioritisation skills and the ability to work under pressure is demonstrated by my ability to examine several batches of supplies simultaneously to meet often tight deadlines. • Experience training colleagues including members of a new quality department set up in Ireland. Feedback received indicated that the training was well delivered and informative and was rewarded with two recognition bonuses. • Project management skills were developed during the implementation of a new process for electronic batch review. This included updating procedures, hosting training sessions and securing support from key stakeholders. • Awarded an ‘Appreciation at Merck’ letter and bonus for my contribution to achieving on-time delivery of supplies and collaboration with multiple functional groups.