Must know process validation cleaning validation verification and hold time studies. Candidate should also have exposure to EU, MHRA, and USFDA regulatory audits.
The candidate must possess a thorough understanding of relevant disease biology, the clinical landscape, emerging technologies, and the competitive environment.
This also includes managing the Per-Subject Cost PSC process for assigned studies, managing escalation and resolution for budget and non-legal term issues from other ICL or pCRO and collaborating with other lines to plan site contracting timelines through start-up.
Skilled in process validation document preparation and review, with strong knowledge of QMS, qualification documents, regulatory audits, and vendor qualification and audits in a regulated environment.
Alembic Pharmaceuticals Limited's rich legacy spanning over a century in the Indian Pharma Industry. With a steadfast commitment to quality and innovation, we continue to make significant strides in the pharmaceutical sector.
Otsuka Pharmaceutical India Private Limited primarily manufacturing IV and parenteral nutrition products across multiple markets and therapeutic segments.