What are the responsibilities and job description for the Pharmaceutical Audit Manager position at The Ritedose Corporation?
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
Salary : $85,000 - $95,000