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.
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.