Experience

Ciall Clinical Services, LLC

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Information Technology QA Advisor

  • Jun 2020 - Present

  Responsible for advising and performing quality assurance activities on matters related to validation and compliance of GxP computerized systems. Includes advising internal Ciall staff; assessing and auditing IT vendors; developing, reviewing validation deliverables, policies, and procedures. Act as Quality Assurance approver of record for validation deliverables. Ensure inspection readiness of clients. Responsible for advising and performing quality assurance activities on matters related to validation and compliance of GxP computerized systems. Includes advising internal Ciall staff; assessing and auditing IT vendors; developing, reviewing validation deliverables, policies, and procedures. Act as Quality Assurance approver of record for validation deliverables. Ensure inspection readiness of clients.



YourEncore

• United States
• Business Consulting and Services
• 1 - 100 Employee

• Managing Expert, Quality Center of Excellence

  • Mar 2019 - Present

  Bringing more than 26 years of experience to YourEncore, Tony works with fellow YourEncore managing experts to provide clients with informed, risk-appropriate decisions to help ensure the compliance and productivity of their business activities. Bringing more than 26 years of experience to YourEncore, Tony works with fellow YourEncore managing experts to provide clients with informed, risk-appropriate decisions to help ensure the compliance and productivity of their business activities.



Alton Ettwein Consultants, LLC

• Book Author

  • Jan 2018 - Present

  "1968 + 50: Looking back at the historic, tumultuous year of 1968," published January 2018. "1968 + 50: Looking back at the historic, tumultuous year of 1968," published January 2018.



Alton Ettwein Consulting, LLC

• Principal Consultant

  • Jul 2017 - Jun 2020

  Quality professional with more than 25 years experience in IT quality and compliance across the GCP, GLP, and GMP (GxP) areas. Managed and participated in internal and external consulting in the related areas of GxP computer validation, risk management, quality project management, and electronic records/signatures including 21 CFR 11. Manager and team member on global IT quality and auditing teams at Pfizer (20 years) and PAREXEL International (4 years). Participated in new process and SOP development at multiple companies. Specialties include IT system consulting and audits at pharmaceutical companies and CROs, and software supplier audits.



PAREXEL

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Computer Technology Compliance Manager

  • Sep 2013 - Jun 2017

  Participate in strategic and operational planning of audits and audit program; work with cross-functional teams to scope, plan, execute and report audit activities in addition to reviewing results of Quality Assurance audits and reviewing/monitoring Corrective Actions and Preventive Actions (CAPAs). Evaluate audit and compliance-related processes and computer validation quality assurance in consultative role with business area clients and external partners. Participate in strategic and operational planning of audits and audit program; work with cross-functional teams to scope, plan, execute and report audit activities in addition to reviewing results of Quality Assurance audits and reviewing/monitoring Corrective Actions and Preventive Actions (CAPAs). Evaluate audit and compliance-related processes and computer validation quality assurance in consultative role with business area clients and external partners.



Pfizer Inc

• United States
• Hospitals and Health Care

• Senior Manager and Senior Auditor

  • Apr 2006 - Sep 2013

  Developed strategies for building and developing corporate Quality Assurance organizations. Ensured that regulated computerized systems are validated according to applicable regulations, guidance, and internal procedures. Experience across GCP, GLP, and GMP areas, including 21 CFR Part 11. Departmental lead and divisional trainer for continuous improvement. Performed numerous audits across the U.S., Europe and Asia. Led corporate Risk Management, Audit Scheduling, and Continuous Improvement teams, as well as the IT Quality Forum.

• Manager, Computer Validation Quality Assurance

  • Jun 1998 - Apr 2006

  Manage personnel, activities, and processes and share management responsibilities for the department's program globally. Provide personnel with guidance in validating computer systems, and assist in the development and administration of corporate policies and standards used to ensure system compliance. Provide training and resources for department. Provide training to other Pharmacia employees, including computer validation and regulations. Performed software vendor audits.



Trilogy Consulting

• United Kingdom
• Marketing Services

• Computer Validation Manager, Project Manager, Technical Writer

  • Jan 1995 - Jun 1998

  Provided IT management services: Provided owners of regulated computer systems with guidance and training.Oversaw group of approx. 12 technical writersProvided training and project management for personnel.Developed, wrote and edited tests, user manuals, and other documentation for regulated computer systems.Performed audits of software suppliers, and participated in the planning and documentation of those audits. Provided IT management services: Provided owners of regulated computer systems with guidance and training.Oversaw group of approx. 12 technical writersProvided training and project management for personnel.Developed, wrote and edited tests, user manuals, and other documentation for regulated computer systems.Performed audits of software suppliers, and participated in the planning and documentation of those audits.



Experis

• United States
• Staffing and Recruiting

• Consultant

  • 1994 - 1998



Medair Equipment Supply

• Manager and Corporate Compliance Officer

  • May 1984 - Jan 1992

  Managed Kalamazoo branch of Medair, which provided medical gases and durable medical equipment to most of the hospitals in Michigan, northern Indiana and northern Ohio.Served as primary contact to hospitals, health care companies, and home care patients.Served as Corporate Compliance Officer for regulated activities, including packaging and labeling of medical oxygen and other gases.Wrote corporate Standard Operating Procedures. Managed Kalamazoo branch of Medair, which provided medical gases and durable medical equipment to most of the hospitals in Michigan, northern Indiana and northern Ohio.Served as primary contact to hospitals, health care companies, and home care patients.Served as Corporate Compliance Officer for regulated activities, including packaging and labeling of medical oxygen and other gases.Wrote corporate Standard Operating Procedures.