Consultant
Professional with years of experience, skilled in analytical chemistry, quality control, quality assurance, quality systems, and regulatory affairs. Highly credentialed and experienced in medical device, drug, and fine chemicals manufacturing industries. Background in needle and infant security device products, diagnostic equipment components, and fine chemicals.
CORE COMPETENCIES
- Quality System Development/Support/Auditing Business Continuity Process
- Quality Control/Quality Assurance Supply Chain/Procurement
- Design Control Training/Training Material/Assessments
- Change Management/21 CFR Part 820
- Risk Management/FMEA/Hazard Analysis ISO 9000/ISO 13485/ISO/TS 16949
- Operating Procedures/Work instructions Process Improvement/Six Sigma
SELECTED ACCOMPLISHMENTS
- Developed quality management systems for compliance with 21CFR Part 820 and ISO13485, and managed various activities for medical device manufacturers of needle and infant security device products, and components of diagnostic equipment, including:
- Performed gap analyses to identify compliance issues, elevating critical concerns to executive management for quality planning purposes
- Developed project plans to prioritize compliance initiative activities and implement associated corrective actions
- Developed quality manuals, standard operating procedures, and other required documents for compliance with applicable regulations and standards
- Supported risk management activities according to ISO 14971, developed associated training material, and provided training for conducting FMEA’s
- Developed training packages for ISO 13485 requirements, carrying out in-depth training to address CAPA and customer complaints
- Conducted precertification audits to assess readiness and prepare companies for ISO certification, providing guidance on how issues may be addressed
- Performed internal audits to ensure overall system compliance with applicable standard operating procedures and work instructions
- Developed processes for chemical manufacturer to analyze drugs in support of pharmaceutical R&D and manufacturing activities, including:
- Developed analytical processes using various instrumental techniques
- Analyzed various drugs using USP methodologies
- Performed quality assurance services by inspecting, performing process audits, and assisting with corrective action requests
- Conducted supplier audits at pharmaceutical raw material manufacturing and packaging vendors
- Provided services to assess training requirements for various manufacturing organizations, including:
- Completed needs assessments for human resource departments to identify training needs for personnel and overall departments
- Developed training materials that considered position of employees and organization’s culture
- Conducted training to include ISO requirements, internal auditing, SPC, time management, conducting meetings, presentation skills, diversity, etc.
- Developed business continuity management processes for vendors of global chemical manufacturing company, including:
- Developed processes to identify and define critical suppliers
- Prioritized suppliers based upon criticality and prepared schedules for visiting sites and performing required gap analysis
- Conducted gap analyses for Asian, European, and US suppliers
- Prepared training manuals and worked with suppliers regarding business planning processes and appropriate methods for responding to business interruptions
- Reduced cost and improved organization’s supply chain and inventory management processes, including:
- Analyzed raw materials inventory at each Asian, European, and US manufacturing plant
- Determined cycle time for each product and established raw material procurement and inventory policy to reduce carrying cost of raw material inventory by 40%
- Worked with suppliers to improve on-time delivery and reduced raw material inspection frequency
- Improved internal processes to reduce manufacturing cycle time
- Established key performance indicators to monitor progress over time
PROFESSIONAL EXPERIENCE
- Balar Quality Systems, LLC, President and Principal Consultant (Washington, NJ) – 7/07 to Present
- Hoechst AG/AZ EM, Director, Global Procurement/Risk Assessment (Branchburg, NJ) – 2/06 to 4/09
- Hoechst AG/AZ Electronic Materials, Director of Quality (Branchburg, NJ) – 1/99 to 2/06
- Hoechst AG/Clariant, FAB Manager (Branchburg, NJ) – 5/97 to 1/99
- Hoechst AG, Materials Manager (Branchburg, NJ) – 5/96 to 4/97
- Hoechst AG, QA/Analytical Department Manager (Coventry, RI) – 6/89 to 5/96
- Hoechst AG, QC/QA Manager (Coventry, RI) – 1/85 to 6/89
- Hoechst AG, Sr. Analytical Chemist/R&D Manager (Coventry, RI) – 7/73 to 1/85
- Yale New Haven Hospital, Clinical Chemist (New Haven, CT) – 3/72 to 6/73
- American Cyanamid, Analytical Chemist (Stamford, CT) – 8/69 to 11/71
EDUCATION
- Master of Science in Total Quality Management, Anna Maria College, MA – 5/95 to 5/96
- Master of Science in Organic Chemistry, Southern Connecticut University, CT – 9/71 to 12/72
- Master of Science in Inorganic Chemistry, Gujarat University, India – 5/66 to 4/68
- Bachelor of Science in Chemistry, Gujarat University, India – 5/62 to 5/66
CERTIFICATION
- Certified Lead Quality Auditor ISO 9001 and ISO 13485 (QMS), RABQSA – 2/04 to Present
- Certified Business Continuity Planner, Business Continuity Institute – 12/10
- Certified Green Belt, AAA – 6/08
TRAINING
- Risk Management/Analysis for Medical Devices/Pharma. Industries Overview (ISO 14971) – 12/12
- IEC 60601-1:2005, Amendment 1 – 11/12
- ISO 13485:2003 Auditor Training – 12/11
- Business Continuity Planning, Business Continuity Institute – 12/10
- Six Sigma Black Belt Training – 6/08
- Sr. Management Leadership Program – 6/04
- Dr. Deming’s Quality Improvement Seminar – 5/94
- Dr. Juran’s Problem Solving Training – 4/90
AFFILIATIONS
- Business Continuity Institute, Associate Membership – ended 12/12
- American Society of Quality, Vice Chair/Executive Board Member (Princeton, NJ Chapter) – 1/05 – 12/08
- American Society of Quality, Sr. Member (Member #00149195) – 7/89 – Present
