Valeant Pharmaceuticals

Principal Quality Auditor

US-NJ-Bridgewater | US-FL-Tampa | US-NY-Rochester
Job ID
9418
Pos. Category
Quality
Pos. Type
Full Time

Overview

Ensure all Valeant sites and applicable global functions are compliant to the applicable country regulations, the applicable ISO standards, and the applicable Quality System elements, Overall objective is to improve our ability to obtain and sustain total quality throughout Valeant.

 

Scope of Position: 

·         Manages Audit Teams of 2 to 3 colleagues

·         Auditor is critical to total quality sustainability which creates freedom to operate as Auditor identifies site capabilities and risks internally prior to external inspections.

·         Intense effort and assessment within short timeframe as audits are typically only a few days.

·         All Valeant sites and global regulated functions are within scope

·         Domestic and international travel (30%)

Experienced in MS Office tools

Responsibilities

  • Prepare, plan, and conduct effective and efficient quality compliance audits of VALEANT manufacturing sites, applicable global functions and distribution centers.
  • Through the audit program, assess the site or function’s ability to operate freely. Communicate the assessment results inclusive of risks, learnings, best practices, etc. to our customers (Senior Management, Site or Functional Management, etc.)
  • Prepare and distribute audit reports
  • Review and approve auditee responses/CAPA plans
  • Prepare and maintain audit schedule per applicable procedure
  • Maintain working knowledge of applicable regulations and standards affecting VALEANT sites and global functions
  • Responsible for implementing changes affecting the compliance department
  • Write/Update departmental and global procedures, as needed
  • Active participation on the Technical Audit Committee
  • Assist in preparing and hosting external audits (FDA, Notified body, etc.), as needed
  • Ability to learn and use learn the company’s enterprise Quality Systems software applications (e.g. Kintana, CQMS (CATSWeb Quality Management System)), QlikView, Documentum (D2), QlikView, etc.)
  • Manage special projects as assigned

Key relationships: 

  • Internal Customers are Site Leaders and Valeant Senior Leadership within Quality, Regulatory, Engineering, Operations, etc. Routine contact through the conduct of audits, audit follow-up and communication.
  • External Customers/Partners are government agency representatives (FDA, ANVISA, Health Canada, etc.) and Notified Body management and auditors.
  • Business Partners/Colleagues worldwide within Valeant sites and functions

Qualifications

  • Bachelor's Degree, Preferred degree in  a science  discipline, microbiology preferred
  • Certified auditor (ASQ CQA or equivalent)
  • Minimum of 8 years of experience in the Pharmaceutical industry, with aseptic fill and some medical device experience preferred. Experience in Quality roles is required.   
  • At least 3 years lead auditor experience in a Pharma environment
  • Working knowledge of US FDA regulations (21 CFR 210, 211 and 820)
  • Working knowledge of ISO 13485 and 14971, preferred
  • Working knowledge of other country regulations (examples – Europe, Canada, Japan, Brazil, Australia, etc.) for drugs; preferred for medical device
  • Manager of Quality or Quality Area is a plus

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