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Audit Manager

The Ritedose Corporation

Columbia, SC

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JOB DETAILS
SKILLS
American Society for Quality (ASQ), Auditing, Biology, Biotech and Pharmaceutical, Chemistry, Code of Federal Regulations, Communication Skills, Corrective Action, Current Good Manufacturing Practice (cGMP), Database Management Software/Systems (DBMS), FDA (Food and Drug Administration), Internal Audit, Interpersonal Skills, Mentoring, Pharmacy, Presentation/Verbal Skills, Quality Management, Regulations, Regulatory Compliance, Vendor/Supplier Evaluation, Vendor/Supplier Management, Vendor/Supplier Quality Management, Word Processing, Writing Skills
LOCATION
Columbia, SC
POSTED
3 days ago

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:
  • 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
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

About the Company

T

The Ritedose Corporation

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