Mark Miles currently serves as the Quality Assurance Director at PolyPeptide Laboratories, where he plays a pivotal role in ensuring that the company adheres to the highest standards of Good Manufacturing Practice (GMP) within the pharmaceutical industry. With a strong foundation in quality systems, Mark...
Mark Miles currently serves as the Quality Assurance Director at PolyPeptide Laboratories, where he plays a pivotal role in ensuring that the company adheres to the highest standards of Good Manufacturing Practice (GMP) within the pharmaceutical industry. With a strong foundation in quality systems, Mark has been instrumental in the development and implementation of critical documentation, including Batch Production Records (BPRs) and Standard Operating Procedures (SOPs). His expertise extends to managing investigations, change controls, and deviations, where he meticulously reviews and approves Out of Specification (OOS) reports and conducts comprehensive Root Cause Investigations.
One of Mark’s significant contributions has been the introduction of an electronic Quality System that streamlines SOP training and review processes, enhancing efficiency and compliance. Additionally, he spearheaded the implementation of an electronic event management system designed to oversee investigations, change controls, deviations, and OOS incidents. This innovative approach has not only improved operational transparency but has also fostered a culture of continuous improvement within the organization.
Mark's journey at PolyPeptide Laboratories began as a key member of a small team responsible for the company's start-up, collaborating closely with industry experts like Dr. Michael Verlander to establish robust quality systems, including equipment and cleaning validations. His commitment to modifying and enhancing these systems ensures that PolyPeptide remains compliant with evolving industry standards, such as the Quality System Inspection Technique (QSIT). With a wealth of experience in validation, troubleshooting, and quality auditing, Mark Miles exemplifies leadership in quality assurance, driving excellence in pharmaceutical manufacturing and contributing to the overall success of PolyPeptide Laboratories.
