Description
SUMMARY Accomplished professional with over 20 Years' experience in Pharmaceutical/Biotechnology industry. Leadership in Quality Assurance, Quality Control, Regulatory Affairs, and Phase Specific GMP (US, EU) Background in Validation, Technology Transfer and R&D. In-depth scientific and technical knowledge of Analytical and Organic Chemistry. Strong managerial supervisory and mentoring skills. Documented record of accomplishments AREAS OF EXPERTISE * Regulatory compliance * Quality Risk Management * Implementation of GMP in manufacturing, packaging and labelling, and in QC Labs * Quality oversite of development and manufacturing of drug products (clinical trial material, commercial products) * Experience in solid dosage, softgel, liquids, topical and parenteral products * Discrepancy and failure investigations * Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations * Corrective and Preventative Actions (CAPA) * Metrics and trending * Supplier Quality Management * Supplier/vendor audits * Qualification of service providers (external laboratories, CROs/CMOs) * Quality Agreements * Continuous Improvement * Remediation * Leading role in regulatory inspections (FDA, MHRA, EMA) * Inspection readiness * Client audits * QA review of CMC section of submissions (IND, IMPD, ANDA, NDA) * Change management * Document Control * Internal Audits * Quality by Design (QbD) * Critical Quality Attributes (CQA) * Development and validation of analytical methods * Multidisciplinary project management * Synthetic organic and medicinal chemistry * Drug discovery and development * Analytical chemistry spectroscopy * Structure elucidation (1 and 2D NMR, MS) * Training, mentoring, team building, consulting * Excellent written and oral communication
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