Senior Quality Assurance Auditor II
Primary Role The primary responsibilities of this position include supporting the internal and external auditing programs, supplier/CMO/CTL qualification program and the material change notification program. This position will be responsible for coordinating and performing internal and external GMP audits as the lead auditor. This position will also support regulatory and third party inspections and Site Master File updates.
Responsibilities 40% Conduct Internal and External cGMP audits as the lead auditor.
* Scheduling and identifying audit agenda
* Lead audit teams including SMEs from functional areas to perform the audit
* Performing the audits using knowledge of regulatory requirements and knowledge of biopharmaceutical operations in areas including but not limited to QC, QA, Manufacturing, Materials Management, Supply Chain, Validation
* Make decision on observations, observation categories, and acceptability of internal and external audit outcome
* Lead author for generation of audit reports
* Make decision on acceptability of responses to internal and external audit findings, and follow up actions required. 20% Execute and continuously improve the following programs using a risk based approach: internal auditing, Supplier/CMO/CTL Qualification, Material Certification, Vendor Change Notification. Conduct assessment using risk based approach and make determination on internal and external audit schedule and scope. 15% Work cross-functionally to continuously improve the Vendor Qualification Program. 15% Maintain detailed understanding of current US and international regulatory requirements. Contribute to the establishment and operation of Quality Intelligence Program to ensure Shire HGT maintains compliance to regulations. 10% Support regulatory and third party inspections Education and Experience Requirements Essential: Minimum requirements include a Bachelor's degree in a technical, preferably a biological science discipline and 8 years auditing experience in pharmaceutical and/or biopharmaceutical industry. Candidate must have experience performing internal and external audits. Additional requirements include a valid passport and driver's license. Desired: ASQ certification or equivalent desired. Ideal Candidate will have been involved in international agency site inspections. Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives
Shire is an Equal Opportunity and Affirmative Action Employer
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