What are the responsibilities and job description for the Principal Quality Auditor position at Bausch Health Companies?
Principal Quality Auditor (7015)
Career Opportunities: Principal Quality Auditor (7015)
Requisition ID 7015 - Posted - Central - Quality - US - Remote - City (385)
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global company that develops, manufactures and markets a range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. Each day, Bausch Health products are used by over 150 million people around the world.
Our approximately 21,000 employees are united around our mission of improving people’s lives with our health care products, and we manufacture and market health care products directly or indirectly in approximately 100 countries.
Position summary:
As a corporate auditor, assess Bausch Health internal manufacturing sites, distribution centers, applicable affiliates and global functions for GxP compliance to the applicable country regulations, the applicable ISO standards, and the applicable Quality Management System requirements and elements to determine risk, opportunities for improvement and best practices.
Overall objective is to improve our ability to obtain and sustain total quality throughout the company.
Key responsibilities:
- Prepare, plan, and conduct effective and efficient GxP quality compliance audits of company manufacturing sites, distribution centers, applicable affiliates and global functions.
- 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 company sites and global functions
- Responsible for implementing changes affecting the Quality Compliance department
- Create and update departmental and global procedures, as needed
- Active participation on the Technical Audit Committee
- Assist in preparing and hosting external inspections (FDA, Notified Body, etc.), as needed
- Ability to learn and use the company’s enterprise Quality Systems software applications (e.g. Trackwise, Compliance Wire, etc.
Qualifications and experience:
- Bachelor's Degree in a technical discipline, microbiology preferred; Certified auditor (ASQ CQA, IRCA, 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 other country regulations (examples –Europe, Canada, Latin America, inclusive of Mexico, Australia, etc.) for drugs; preferred for medical device
- Working knowledge of ISO 13485 and 14971, preferred
- Manager of Quality or Quality Area is a plus
- Bi-lingual a plus (English & Spanish)
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This position may be available in the following location(s): US - Remote
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.
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Bausch Health is an EEO/AA employer M/F/D/V.
