GMP Auditor (Project-Based)
GMP Auditor (Project-Based)
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Salary Not Disclosed
1 Vacancy
Job Description
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This role is a projectbased consulting opportunity.
Responsibilities:
- Independently conductGMP vendor qualification audits to include but not limited to manufacturing labeling packaging and/or testing facilities
- Create audit related documents including audit plans and reports
- Collaborate with vendors and sponsors to plan and implement an audit schedule
- Oversee and monitor CAPA process
- Experience with hosting and interacting with regulatory authorities during an inspection
- Minimum 10 years of experience in GMP auditing role within the CRO Pharma or Biotech industry
- Bachelors Degree in a scientific medical or clinical discipline
- Travel required for onsite audits
- Experience with hosting and interacting with regulatory authorities during an inspection preferred
- Must be knowledgeable in 21 CFR Partsand 820
- Must have extensive experience auditing GMP facilities including DP/DS and/or device manufacturing and QC Laboratories
- Expert knowledge of scientific principles and concepts
- Proficiency with MS Office applications
- Handson experience with clinical trial and pharmaceutical development
- Excellent communication skills and willingness to work with others to clearly understand needs and solve problems
- Excellent problemsolving skills
- Proficient experience with FDA and GMP requirements
- Basic understanding of CROs and scientific and clinical data/ terminology and the drug development process
Required Experience:
Senior IC
Employment Type
Part-Time
