Audit Manager (Columbia)The Ritedose Corporation • Columbia, South Carolina Metropolitan Area, US
Audit Manager (Columbia)
The Ritedose Corporation • Columbia, South Carolina Metropolitan Area, US
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job_description.job_card.job_descriptionFour 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
The 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 :
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Audit Manager • Columbia, South Carolina Metropolitan Area, US