Principal Quality Auditor

Job Description:

Responsible for leading and conducting global quality system audits to assure that all sites and departments within B&L implement and maintain and appropriate quality system and adhere to B&L policies and the laws and regulations of the countries in which products are produced and marketed.

Responsible for leading and conducting audits of contract manufacturers and suppliers relative to corresponding quality systems and regulatory standards and requirements. This includes audit planning, execution, documentation and reporting with proactive follow up with CAPA.

Responsible for the development and maintenance, as a recognized technical resource, of quality systems that adhere to B&L compliance policies and procedures and the laws and regulations of the countries in which products are produced and/or exported.

Responsible for the communication and documentation of internal and external compliance-related information including changes in regulations, new guidelines and guidance documents and other information from regulatory authorities and trade organizations to all B&L sites.

Responsible for continuous improvement initiatives to ensure that B&L continues to meet expectations in an evolving regulatory environment while striving to meet business excellence goals.

Inform senior management on an ongoing basis about the compliance status in all areas of the business and highlight any delays and resource constraints that could adversely impact the business.

Manage global quality projects as directed by supervisor, including developing and or obtaining necessary materials and leading training in the area of quality system requirements as defined by B&L Policies and Procedures and the regulations.

Support external third party audits conducted in Rochester. Train and support global auditors and monitor their performance and compliance to global requirements.

Responsible for conducting special investigations that are highly sensitive in nature (data integrity investigations, due diligence assessment, etc.).

 

Qualifications:

Education: Bachelor?s Degree in Chemistry, Biology, Microbiology or related field. Advanced degree is a plus.

Experience: Eight or more years of technical experience in a quality related function in a pharmaceutical and or medical device environment, responsible for developing and implementing quality systems that includes at least four years of Pharmaceutical GMP?s with a knowledge of Device QSR?s and ISO 13485:2003.

ASQ Certification, CQA Certification, ISO 9000 Lead assessor certification required. Leadership skills, computer literate, strong written, oral communication, interpersonal skills and strong Medical Device or Pharmaceutical background required. Biological/Micro biology background preferred. Environmental monitoring/Aseptic experience. Demonstrated hands on ability to lead cross functional audit teams.

ISO, GMP?s, GLP?s, MDD, GCP?s desired. Knowledgeable of FDA requirements and experience with managing agency audits. Must be certified or certifiable as an auditor through education and experience.

 

Please Apply Online: www.bausch.com Reference Job Code: 2936BR