Technical Agreements Expert
CurrentDuring my posts in Pharmathen (key responsibilities & achievements)- Created and managed company’s and affiliates quality agreements with all suppliers (API, excipients, packaging, contract labs, services) and customers - Increased the number of signed q.agreements by 10x- Created and/or improved existing quality agreement templates- Improved the compliance of company’s practices to quality agreements- Advised Legal/Business Dpts on quality parts of commercial contracts- Supported Quality Dpt (corporate & locals) on suppliers’ evaluation; contractors management; complaint handling; CAPA drafting; audit reports correspondence; PQR drafting- Created and/or improved relevant SOPs- Participated in customers audits and Authorities inspection to contractors’ premises as company’s liaison- Participated in the implementation of serialization project- Supported R&D dpt on new product projects / FDA submissions- Supported on Products’ launch- Experience in GMP (EU, MHRA, FDA, Brazil, S.Africa), ISO (9001, 13485) standards- Managing small quality team