Description
Global pharmaceutical company is seeking a Global Quality Auditor to Join their team.Purpose: provide objective audits of internal GXP systems and external businesses for the company Management in order to accurately depict the status of compliance and to foster improvements based on current GXP references and interpretations.
*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 Inc. 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.
Here are the qualifications required for this position:
*Minimum of a Bachelor of Science Degree and a minimum of 4 years of relevant quality experience is required. However, a combination of experience and/or education will be taken into consideration.
*Auditing Certification any advantage but not essential (either by independent body or by corporate program)
*Possess a good knowledge of national, international, and supranational cGMP regulations and expectations sufficient enough to readily interpret, lead discussion, and provide guidance based on the applicability of the regulations to the subject being audited. Must be familiar with all other GXP concepts.
If you would be interested in hearing more about the role and company please call me Anna Mooney or reply with an upto date CV.