Pamela Farr

Quality Manager Cleveland Ohio, Walton Hills Ohio, Independence Ohio @Valtris Specialty Chemicals

Bedford, OH, US
MOBILE NUMBERS
+14•••••••02

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WORK HISTORY

Feb 2015 — Present

Quality Manager Cleveland Ohio, Walton Hills Ohio, Independence Ohio @Valtris Specialty Chemicals

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Quality Manager two Manufacturing Sites and an RD Center - Cleveland, Walton Hills and Independence OhioCertified ANSI/NSF/IPEC 363 GMP for Pharmaceutical Excipients AuditorSuccessful Implementation and certification of EXCiPACT Good Manufacturing Practices for Pharmaceutical ExcipientsDeveloped and implemented a customer compliant ISO13485 Medical Device Standard at manufacturing siteDeveloped cGMP Elemental Impurities Profiles, Validation, and Risk Assessment for Pharmaceutical ExcipientDeveloped and generated Pharmaceutical Excipient Packets targeted to pharmaceutical drug manufacturers to decrease filling out quality surveys from customersSuccessful UL (Underwriters Laboratory) and FM Audits which allowed the site to become the North America toll producer for significant business in transformer oils. Certified Lead RC 14001 (Responsible Care Health, Safety, Environmental and Security) AuditorImplementation and certification of RC14001 and ISO9001:2015

EDUCATION

1980 — 1984

The Ohio State University

Bachelor of Science (B.S.),, Education

ABOUT PAMELA FARR

Dynamic, results driven manager in quality management positions. Proven track-record in assessing current operations, developing programs to drive product and operational improvements. Change agent for site’s Quality Culture. Extensive knowledge and skills in development, implementation and maintenance to ISO9001 Standards, EXCiPACT Good Manufacturing Practices/IPEC 363 GMP for Pharmaceutical Excipients, and ISO14001/OHSAs18001/RC14001 Health, Safety, Environmental and Security Standards. Exceptional ability to work with various functions and customers to achieve business objectives. Seasoned professional with high standards for quality, continuous improvement, customer satisfaction, and market leadership. Specialties: ISO9001:2015 and TS16949 Quality Management Systems ANSI/NSF/IPEC 363 GMP for Pharmaceutical Excipients cGMP - Good Manufacturing Practice Root Cause Analysis (5 WHYs, Fishbone Diagrams, etc) Audits (Internal, External Audits including customer and ISO certification Audits) Corrective and Preventive Actions including Customer Complaint Investigations SPC (Statistical Process Control) 5S Lean Manufacturing ISO14001 Environmental Management System OHSAs 18001 Safety Management System RC14001 – Responsible Care Health, Safety, Environmental and Security Management System Factory Quality Control

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