p>Knowledge and Skills (Functional / Technical) Extensive knowledge of quality tools: CGMP Validations and Qualifications Regulatory guidelines US Pharmacopoeias Internal auditing Handling of regulatory Inspections Well acquainted with QMS and CSV Well versed with Change control/deviations and market compliant management system Strong understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Documentation Practices (QDP); and ICH Q8, Q8, and Q10 procedures Proficiency with Microsoft Word, Microsoft Excel, and Power Point is required Strong documentation skills are required Experience with comparative Statistical techniques, sampling plans, GR&R, hypothesis testing, ANOVA, parametric and non-parametric analysis are also desired. The position will lead a team of In-Process Quality Assurance (IPQA) team providing oversight to QA aspects of Pharmaceutical Manufacturing including but not limited to shop floor activities like line clearances, walk throughs, documentation verification, IPQA checks for manufacturing and packaging processes, AQL, BPR revision, sample management, retain samples program, visual inspection program and notification of hold for equipment, rooms, utilities etc.