Description
A Global leader within in the pharmceutical industry is seeking a Global Quality Auditor.ESSENTIAL DUTIES AND RESPONSIBILITIES
-Prepare and conduct internal and external audits for the company
-Perform independent research of required topics and FDA, EMEA, TGA, Health Canada, WHO, PIC/S, MHLW, and other national, international, or supranational regulations (GxP and ICH) including assessment of applicability and impact on systems being audited.
-Provide independent review, comprehension, and discussion of departmental and corporate policies and procedures with multiple levels of employees and Management.
-Provide interpretation of complex regulations through research of current corporate and governmental expectations.
-Facilitate opening and closing audit meetings with all levels of Management.
-Perform GXP audits based on a defined audit plan within specific time constraints.
-Prepare all associated documentation including audit plans and audit reports under strict confidentiality.
-Provide guidance and support in the development of corrective actions based on GXP principles and current industry standards.
-Track and monitor audit responses and the implementation of corrective actions.
-Author and approve Quality Compliance procedures.
-Serve as a compliance reference regarding GXP Interpretations for all levels of Management.
-Serve as a liaison within the many GXP departments of the company to effectively establish compliant quality systems.
-Plan, schedule, and arrange travel to various sites based upon guidance from Management.
-Requires domestic and international travel (approximately 50% of the time).
-Perform other duties as assigned.
EDUCATION/EXPERIENCE
-Minimum of a Bachelor of Science Degree
-3-5 years exeperience in a similar role
If you are interested in this great opportuntiy please contact me Anna Mooney or apply below with an up to date CV.