Pharmaceutical Audit Manager

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

Strong communication skills, verbal and written

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