Sr. Validation & Compliance Specialist, Pharma-Bio Serv
SME with proven experience in project management, statistical analysis, validations, manufacturing and packaging in solid, semi solid and liquid dosages pharmaceutical products. Knowledge on Quality Risk Management and Risk Based Approach to Cleaning Validation. Validation experience covers project management, technology transfer, process development/scale-up/validation of pharmaceutical manufacturing/packaging processes, manual and automatic cleaning procedures development and validation, bulk holding time studies, investigations, performance qualification, product/process characterization, new product development and validation. Proven background in scheduling, troubleshooting, registration, audits/assessments, preparation of validation documentation, strategies, mater plans, and all related regulatory documentation required for FDA approval.