The Pharmaceutical Audit Manager is responsible for the internal audit program, supplier quality management and coordination / execution of customer and regulatory audits.
Responsibilities :
Ensure execution of internal audits according to the Internal Audit Master Plan
Track the execution of corrective action implementation of audit findings
Provide oversight to supplier quality management process
Conduct supplier audits including on-site inspections when required
Maintain a history of audits performed and schedule repeat audits as required
Coordinate and manage supplier quality alerts
Coordinate and participate in regulatory and customer audits
Perform trending of audit findings and identify opportunities for improvement
Maintain current knowledge of regulations and guidance documents
Manage and mentor audit personnel
Qualifications :
Four year college degree in Pharmacy, Chemistry, Biology or related field
5-10 years' experience in the pharmaceutical industry with a quality background
Thorough knowledge of cGMP / 21CFR with related experience in regulatory and compliance
ASQ Certified Quality Auditor required
Experience with FDA audits
Proficient with current word processing and database software
Strong interpersonal / group skills with ability to motivate and direct others