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