cGMP
cGMP (Current Good Manufacturing Practice) is a quality management system used in pharmaceutical and healthcare companies to ensure products are consistently made and controlled according to quality standards. Think of it as a set of rules and guidelines that companies must follow to make sure medicines and medical products are safe for people to use. It's like having a very detailed recipe book that everyone must follow exactly the same way every time. The word "current" means these practices are regularly updated to stay modern and effective. Companies that don't follow cGMP guidelines can get in trouble with regulators like the FDA.
Examples in Resumes
Led quality control team ensuring cGMP compliance in vaccine production
Developed and maintained cGMP documentation for medical device manufacturing
Trained staff on cGMP procedures and FDA regulations
Conducted internal GMP audits and implemented corrective actions
Typical job title: "Quality Assurance Specialists"
Also try searching for:
Where to Find Quality Assurance Specialists
Professional Associations
Job Boards
Professional Networks
Example Interview Questions
Senior Level Questions
Q: How would you handle a major GMP compliance issue in production?
Expected Answer: A senior professional should discuss steps including immediate production stoppage if needed, investigation process, documentation, corrective actions, preventive measures, and communication with regulatory authorities if required.
Q: How do you stay current with cGMP regulations and implement changes?
Expected Answer: Should explain monitoring FDA/regulatory updates, risk assessment processes, change management procedures, and methods for training staff on new requirements.
Mid Level Questions
Q: What are the key components of a cGMP audit?
Expected Answer: Should mention documentation review, facility inspection, employee training records, quality control procedures, and how to write clear audit reports.
Q: How do you ensure proper documentation in a cGMP environment?
Expected Answer: Should discuss the importance of accurate record-keeping, review processes, signature requirements, and maintaining proper documentation trails.
Junior Level Questions
Q: What are the basic principles of cGMP?
Expected Answer: Should explain fundamental concepts like proper documentation, following procedures, maintaining clean facilities, and the importance of training.
Q: Why is documentation important in cGMP?
Expected Answer: Should discuss how documentation proves procedures were followed correctly and helps track any issues if they arise.
Experience Level Indicators
Junior (0-2 years)
- Basic understanding of GMP requirements
- Following standard operating procedures
- Basic documentation practices
- Quality control checks
Mid (2-5 years)
- Internal auditing
- Writing procedures
- Training other staff
- Investigation of quality issues
Senior (5+ years)
- Managing quality systems
- Regulatory compliance strategy
- Leading audit responses
- Quality risk management
Red Flags to Watch For
- No knowledge of basic GMP principles
- Poor attention to detail
- Lack of documentation experience
- No understanding of quality control processes
- Unable to explain importance of following procedures
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