Mawethu Mema

Experienced Quality Assurance and Systems Leader with 10+ years in GMP and ISO-regulated pharmaceutical and biotech environments. Expert in implementing, maintaining, and optimizing Quality Management Systems (QMS) across GxP domains. Proven track record in complaint management, deviations, CAPAs, PQRs, product release, regulatory inspections, training, GDP compliance, and supplier management. Strong cross-functional leadership, problem-solving, and digital systems expertise.

• Designed and launched a comprehensive training program in 2024, boosting compliance and operational capability across the organization.
• Presented at the Honeywell Software Symposium (2023) in Dallas, Texas, sharing insights on optimizing Quality Management Reviews in vaccine manufacturing.
• Successfully implemented TrackWise Digital EQMS, streamlining quality systems and ensuring alignment with global standards.

• Mawethu Mema
• Senior Quality Assurance Professional
• Cell: +27 83 474 9132
• Email: memamawethu@gmail.com
• Location: Cape Town, South Africa
• LinkedIn: www.linkedin.com/in/mawethu-mema
• Date: 2025-07-16
• To: Hiring Manager
• DI Regulatory Consultants
• Cape Town
• Re: Application for the Position of Quality Assurance Officer
• Dear Hiring Manager
• I am writing to express my keen interest in the advertised position of Quality Assurance Officer at DI Regulatory Consultants. With over a decade of experience in GMP-regulated environments, and a proven track record of implementing and maintaining robust Pharmaceutical Quality Management Systems, I am confident in my ability to make a meaningful contribution to your team.
• In my previous role as Quality Systems and Training Lead at Biovac, I led quality systems governance, document control, and regulatory compliance initiatives. My responsibilities included oversight of CAPAs, change controls, deviations, Quality Risk Management, and regulatory inspections. I have authored and maintained critical GMP documentation, and I successfully implemented TrackWise Digital for enhanced QMS performance.
• My experience also extends to managing product complaints, recalls, and customer feedback, leading technical agreements, and conducting third-party and self-inspections. I've consistently ensured readiness for SAHPRA inspections and have played a key role in aligning internal practices with global quality standards and PIC/S guidelines.
• In addition to my technical expertise, I bring strong interpersonal skills, analytical thinking, and a commitment to continuous improvement.
• I am enthusiastic about the opportunity to join DI Regulatory Consultants, a company known for its commitment to regulatory excellence. I am confident that my background in QMS implementation, audit readiness, and quality oversight aligns seamlessly with your expectations for this role.
• Thank you for considering my application. I would welcome the opportunity to further discuss how I can support your quality objectives. I am available for an interview at your convenience.
• Warm regards