Independent Contractor CGMP Auditors

  • Information Technology
  • Full time
  • 2 years ago
  • India ,Bangalore ,Hyderabad

Job Information

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    Salary INR - Indian Rupee 100,000 - 200,000 / Monthly
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    Shift Morning
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    Job level* Executive
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    Job experience* 1+ year
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    Job qualification* B.Tech/BE - Bachelor of Engineering

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)
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