Elmer Rivera serves as the Director of Quality Assurance at SHL Medical, bringing over 24 years of extensive experience in the Pharmaceutical and Medical Device Industry. In his current role, Elmer is pivotal in ensuring compliance with all applicable regulations, including current Good Manufacturing Practices...
Elmer Rivera serves as the Director of Quality Assurance at SHL Medical, bringing over 24 years of extensive experience in the Pharmaceutical and Medical Device Industry. In his current role, Elmer is pivotal in ensuring compliance with all applicable regulations, including current Good Manufacturing Practices (cGMP) and 21 CFR Part 11, across all operations at the assigned site. His leadership is instrumental in fostering a culture of quality and compliance, as he oversees the development and implementation of robust Quality Assurance protocols that align with corporate standards and regulatory requirements.
Elmer's expertise spans a wide array of critical areas, including Quality Control, Auditing, and Vendor & Supplier Management. He has successfully led key projects focused on the commissioning and qualification of facilities, utilities, and equipment, ensuring that all systems meet stringent regulatory standards. His proficiency in Computer System Validation Life Cycle and Data Integrity further enhances SHL Medical's commitment to maintaining high-quality standards in product development and manufacturing.
A strong advocate for cross-functional collaboration, Elmer excels in leading diverse teams through complex projects, utilizing his skills in strategic planning and risk management to drive continuous improvement initiatives. His commitment to training and development ensures that all team members are well-equipped to uphold the highest quality standards. With a keen focus on data analysis and record management, Elmer plays a crucial role in batch release processes and complaint investigations, reinforcing SHL Medical's dedication to delivering safe and effective medical devices to the market. Through his leadership, Elmer Rivera not only enhances operational excellence but also contributes significantly to the overall mission of SHL Medical in advancing healthcare solutions.
