Job Description
Responsible for Good Manufacturing Practice (GMP) audits of manufacturing facilities. Minimum qualifications include:
- Bachelors degree (BA/BS) preferably in engineering, biological or medical sciences, chemistry, or related discipline
- A minimum of ten years experience in Current Good Manufacturing Practices (CGMP) auditing activities and techniques
- A minimum of five years experience vendor/supplier and finished product auditing
- A minimum of five years internal auditing experience
- A solid understanding of manufacturing principles and expertise in FDA CGMP regulations/guidelines and ICH CGMP Guidelines (experience with 21 CFR Part 11 and international regulatory agencies a plus)
- Demonstrated ability to work in a team environment
- Ability to travel to conduct audits
- Effective interpersonal skills; ability to work with all levels of personnel
- Effective oral and written communication skills, ability to communicate issues accurately and precisely
- Attention to detail, accuracy, and completeness
- Strong computer skills (MS Word/PowerPoint/Excel)