4-5

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 scientist with expertise in trace level quantification of GTI/ Nitrosamines/Nitrites or similar impurities using LC-UV/FID, Ion chromatography and LCMS. Ensure all own activities are aligned with overall drug development process. Work according to appropriate SOPs, GMP, GLP, QM, HSE, ISEC & Novartis Guidelines; Strategic and scientific contribution to Networks, target achievements according to net-work charter and annual objectives

Ensure projects are kicked off appropriately and required information defining the scope of the project is properly identified. Ensure that a project schedule encompassing project scope and associated details is accurately developed and regularly maintained.

2-8 years of experience in BMR, QMS, PQR, Qualification, AQA, ERP, Control Sample, Process Validation.

Analyst worked in AMT, AMV section having exposure to HPLC, GC, IC, AAS. Analyst worked in GLP Section having exposure instrument calibration, Qualification, Standard Management, Working Standard qualification.

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.

Otsuka Pharmaceutical India Private Limited primarily manufacturing IV and parenteral nutrition products across multiple markets and therapeutic segments.