| | | 20,000+ Fresh Resumes Monthly | |
|
|
| |
Click here or scroll down to respond to this candidateCandidate's Name
PHONE NUMBER AVAILABLE EMAIL AVAILABLE LINKEDIN LINK AVAILABLEQUALITY MANAGEMENTRisk Management / Regulatory Compliance / cGMP Data Integrity Effective, strategic Quality Director with progressive experience in Quality, Risk, Data Integrity, and Compliance. Support early development and commercialization of pharmaceutical products including sterile-fill finish and highly potent compounds. Possess excellent analytical and problem solving, prioritization, organizational project management, and team building skills. Key competencies include: Data Integrity Compliance and Implementation cGMP Regulations for FDA and EU Site Audit Readiness & Internal/Supplier Audit ICH/USP/EP Compliance CSA-CSV for QMS/LIMS/SAP Team Building and Facilitation Quality and Information System Integration Cross-Functional Collaborative Leadership KEY ACCOMPLISHMENTS 20+ years of Pharma cGMP experience, including cGMP-compliant aseptic sterile manufacturing. ASQ Certified Quality Manager and Lead Quality Auditor. Analytical Laboratory Manager for 5 years. Two Masters Degrees in Chemistry and Software Engineering. Educated in Management Accounting. QUALITY, RISK, AND DATA CONSULTING EXPERIENCESmartLabs, Execute LLC., Boston, MA (2022) Introduced Cleanroom as a service with all Quality Controls Azzur Cleanrooms on Demand, LLC., Waltham, MA (2021) Managed cleanroom clients for complianceUltra-Tab Laboratories, Inc., Highland, New York (2021) Prepared the client and faced the FDA Inspection QuVa Pharma, Inc., Bloomsburg, New Jersey (2021) Compliance to 503B Compounding compliance and KPI AmbioPharm, Inc., North Augusta, South Carolina (2020) Data Integrity compliance and implementationNorthStar Medical Radioisotopes, LLC, Beloit, Wisconsin (2020) Device compliance & FDA Audit readinessOlon Ricerca Bioscience, LLC., Concord, Ohio (2019) CDMO Service compliance and client managementEtQ, Inc., Farmingdale, New York (2013) Software consultant for Computer System Validation Cutler Solutions, LLC., Cherry Hill, New Jersey (2013) GLP Compliance Audit and Management consultingDuke Clinical Research Institute, Durham, North Carolina (2013) Trained as a GCP Compliance AuditorEXPERIENCEPFANSTIEHL, INC., Waukegan, Illinois May 2016 May 2019 Supplier Quality Manager Re-engineered Supplier Management for critical materials and services of a high-potent API manufacturer. Audited Contract Laboratories/Manufacturers and Material/Service Suppliers globally for cGMP compliance. Adapted process approach, risk management, and performance reporting by tightly integrating the Laboratory Information, Management, and Quality Systems with the Information Management System. Effectively facilitated continuous improvement projects through Lean, A3, and Six Sigma methodologies. Ravi Nadarajah 216-288-7565 EMAIL AVAILABLE Page 2 of 2 SIGMA-TAU PHARMASOURCE, INC., Indianapolis, Indiana December 2013 April 2016 Senior Site Compliance Manager and Supplier Quality Auditor Directed compliance program for a sterile fill-finish Biologics facility manufacturing parenteral orphan drugs. Hosted FDA, EU, and other global regulators. Led Supplier Quality and Internal audits for FDA/EU compliance and JIT manufacturing. Negotiated Quality Agreements for critical supply. Led Management Reviews, Material Review Board, Change Control Board, and Deviation Control Board. Globally audited suppliers of drug products/substances manufacturing, release/investigational/stability testing, animal testing, cell banking, excipients, warehouse/distribution, packaging, and process aids. TEDIA COMPANY, INC., Fairfield, Ohio July 2002 December 2012 Quality Assurance Manager Started as the Analytical Laboratory Manager. Promoted as the first full-time Manager to nurture Quality. Introduced Quality culture and formalized Quality system first, before becoming compliant with ISO/cGMP. Validated quality system for FDAs 21 CFR parts 11/211/820, ICH, Pharmacopeias, and ISO requirements. Validated LIMS, ERP, intranet portal, and spreadsheets. Full life cycle software validation management. Ensured DEA, EPA, OSHA, and DOT compliance. Integrated Quality and Information Management System. EDUCATIONMS, Software Engineering, Brandeis University, Waltham, MA, 1999 MS, Chemistry, University of Maine, Orono, ME, 1993 CERTIFICATIONS & MEMBERSHIPSASQ Certified Quality Auditor 2007ASQ Certified Manager of Quality / OE 2008ASQ Certified Supplier Quality Professional 2016RABQSA Certified ISO Lead Auditor 2007 and 2016Member of Regulatory Affairs Professional Society 2012 Senior Member of American Society for Quality 2009 TRAINING & AWARDSASQ trained preliminary Judge, International Team Excellence Award 2013, 2016 IPEC-Americas excipient GMP Auditing workshop 2014 Palladium-trained balance scorecard Facilitator 2012 |
