Shahriar Mohsin

- Accountability of CMO business continuity and support to product extensions in the CMOs of responsibility. - CMO ́s Regulatory Compliance and Quality System adherence and improvement during the overall contract life cycle. - Quality Culture establishment and improvement in the CMOs through Quality Management Review, Training, Technical Visits, periodic meetings, Quality Audits support and partnership with Supply Chain, CMO Management and Regulatory Affairs

- Define and monitor internal quality management system - Ensure effective In-Process Control - Ensure statutory and regulatory compliance are regularly monitored and followed - Prepare, review and update SOP - Handle nonconformities, out of specifications and plan corrective and preventive actions - Change control management - Operate internal training and audits - Prepare and review product quality review (PQR) - Compliance towards timely batch releases and product launches for clients worldwide

Regulatory Affairs: - Compile product folders for national and international authorities - Support product development in compliance with corresponding regional regulations - Support business partners for necessary product registration documents - Examine and approve change control and organize training - Operate internal and external audits QM: - Establish requirements of GMP - Secure and monitor quality by internal ERP system - Complaint management and plan CAPA

- Ensure product compliance in accordance with cosmetic regulations (EU, FDA) - Generate required information for worldwide markets (Raw material information, Safety data sheet, Product information file etc.) - Organize product testing in external laboratories - Communicate with R&D department and support and monitoring product development - Response to clients for various regulatory requests - Implement GMP standards.

Master thesis: Identification and characterization of novel inhibitor against human E-NTPDase1 for cancer immunotherapy

Internship: Genotypic characterization of four T-DNA insertion lines of Arabidopsis thaliana

Biochemistry Biotechnology Bioinformatics Cell biology Bioethics Economics

Pharmacology Pharmacognosy Medicinal chemistry Pharmaceutical technology Organic pharmacy Inorganic pharmacy Pharmaceutical biotechnology Molecular & Cellular biology Regulatory affairs Pharmaceutical management Physiology Biochemistry