3-4

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.

B.Pharm / M. Sc; Handling the Lab instruments of HPLC, Dissolution, D. T., Apparatus, Weighting Balance, Friability, Hardness Tester, FTIR, UV-Spectrophotometer. Analysis of Raw Material, In-process, Finish Products, Stability Tastings, Process Validation, Participate in Lab incident/OOS/OOT/Analytical Deviation.

HPLC, GC method development for OSD & API having exposure to regulated, Semi Regulated and India markets including Complex generic, F2F, Topical and Dermaceuticals, Peptides, Oncology.

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.

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

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.