EMMA International leverages their expertise in pharmaceutical investigations and regulatory compliance to support highly regulated pharmaceutical processes. With over two years at EMMA, the focus has been on ensuring adherence to quality systems and compliance frameworks, playing a critical role in enhancing operational excellence. Core competencies include GMP compliance, SOP development, and quality-related audits, encompassing change control, deviations, CAPAs, and internal audits, technical writing, and pharmaceutical manufacturing investigations.
Previous experience includes consulting with Compliance Insight, where contributions supported a successful EU pre-approval inspection (PAI) for advanced T-cell immunotherapy products. Additionally, extensive work with supplier quality ensured robust evaluation and qualification of materials. This collaborative approach demonstrates a commitment to maintaining safety and compliance while promoting innovation in pharmaceutical manufacturing.More...