• ICH, GCP, USFDA & GAMP Guidelines.
• Principles of Pharmacology & Drug Discovery & Development.
• Good knowledge on Validation and Chromatography.
• Essential Documentation filling & maintenance in Clinical Research & Regulatory Submissions.
• Informed Consent process, enrollment, Case reports, Study reports, Source documents.
• IEC / IRB submission or notification procedure for approval of Study Procedure.
• 21 CFR Part 11.
• E2A Guidelines.
• Demonstrated proficiency in composing written communications.
• Excellent Interpersonal skills to behave in a best possible ways with the visitors in the company.
• Proficient in the use of Microsoft Windows and Office software, a calculator and...