Valeant Pharmaceuticals Sr. Supplier Quality Auditor in Rochester, New York
The Sr Supplier Quality Auditor will assess the level of compliance of Valeant Pharmaceutical’s External Manufacturers with applicable cGMP and regulatory standards (e.g. 21 CFR parts 11, 58, 201-211, 820, 111, ISO 13485, ISO 9001, ISO 17025, ICH Q7) as well as Valeant’s quality standards.
Schedule, plan, execute, report, follow-up and close supplier audits (GMP, GLP, GCP)
Support preparation of annual Regional Supplier Audit Schedule
Prepare and report supplier audit metrics
Monitor and track supplier audit corrective action plans
Member of the Technical Auditing Committee and sub-teams
Develop and enhance Supplier Quality Audit Systems to reduce risk and increase compliance
Conduct Regional Compliance audits
Participate in Good Clinical Practice audits
Conduct For Cause Audits
Monitoring FDA audits and other regulatory actions regarding suppliers
Scope of position:
This position will require travel of 20 weeks or greater.
Support Valeant US Region External Manufacturer annual audit schedule.
Conduct company audits of External Manufacturers with critical compliance and quality risks (i.e For Cause)
Responsible for Supplier Quality Management of limited Regional Service Providers such as Stability Labs and other services.
Internal customers include supplier quality managers, engineers, Regulatory Affairs, Pharmacovigilence, R&D, GPSS ,Supply Chain
External customers include suppliers of products and services for pharma, devices and consumer
BS Degree in a scientific/technical discipline (Chemistry, Microbiology, Engineering)
Certified Quality Auditor (ASQ or other)
Extensive training in Quality Assurance concepts and applications including Internal Auditing, Supplier Auditing, Quality Engineering, Sterility Assurance, Statistics. Basically well rounded in the science of QA.
Excellent writing skills.
Minimum of 5 years of experience in FDA regulated industries (pharmaceuticals and medical device) with 5 years in a cGMP audit role. Prefer a person which has both pharmaceutical and device experience.
Working knowledge of 21 CFR 11, 210, 211, 820, 111, ICH, ISO 13485
Job ID 7676
Location US - NY - Rochester
Pos. Type Full Time