Mishkah Gamieldien

Background

About Mishkah Gamieldien

As a Quality Assurance Officer in the pharmaceutical third-party manufacturing sector, I specialise in ensuring the highest standards of quality management systems (QMS) across a range of processes. My expertise spans the creation and maintenance of Standard Operating Procedures (SOPs), Technical Quality Agreements, batch release reviews, risk assessments, Corrective and Preventive Actions (CAPAs), deviations, and Annual Product Quality Reviews (APQRs). I am also adept at liaising with manufacturers to ensure seamless coordination of contract manufacturing processes. A core part of my role involves Out of Specification (OOS) and Out of Trend (OOT) investigations, ensuring that every aspect aligns with regulatory expectations. I am involved with the development and upkeep of critical documentation, such as the Site Master File and Quality Manual, to maintain operational excellence and compliance. Additionally, I actively participate in both on-site and desktop audits, ensuring that facilities meet stringent GMP (Good Manufacturing Practice) requirements, which are central to everything we do. Having earned a BSc (Hons) in Physiotherapy, my clinical knowledge informs my approach to product safety and efficacy, allowing for a deeper understanding of the pharmaceutical landscape. Working for a relatively smaller company has significantly broadened my professional horizon, allowing me to engage in cross-functional roles that include data management using IMS databases, the creation of marketing materials, conducting training sessions, and designing company profiles and presentations. I am passionate about maintaining the integrity and quality of pharmaceutical products and continually strive to enhance both internal processes and external collaborations.