4-5

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

Identify and develop new business opportunities in global markets. Build and maintain strong relationship with international clients and partners Assist contract negotiation proposals and strategic planning for business growth.

Having surrounding knowledge of HPLC, GC, IR, UV, Dissolution and other QC equipment. Granulation, Compression, Coating, Inspection, Capsule Filling and Wurster coater.

Hands on experience on HPLC, BU, CU, Dissolution Profile , Qualification of QC Instruments and Equipments

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 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.