Candidates having experience in monitoring and handling of shop-floor activities for Tablet, Capsule, Ointmnet, Ampoule, Vial and Injectable production operations, online documentation like log book & batch records and QMS
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.
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.