GMP
GMP (Good Manufacturing Practice) is a system of rules that pharmaceutical companies must follow to ensure their products are consistently produced and controlled according to quality standards. Think of it as a strict recipe book that everyone in pharmaceutical manufacturing must follow to keep medicines safe. When you see GMP on a resume, it means the person understands these important safety and quality rules. Similar terms you might see are "cGMP" (current Good Manufacturing Practice) or "FDA GMP" - they all refer to the same concept of following strict quality guidelines in making medical products.
Examples in Resumes
Led quality assurance team ensuring GMP compliance in vaccine production
Implemented cGMP procedures for new pharmaceutical product line
Conducted GMP audits and prepared documentation for FDA inspections
Trained production staff on FDA GMP requirements and procedures
Typical job title: "GMP Specialists"
Also try searching for:
Where to Find GMP Specialists
Professional Organizations
Job Boards
Professional Networks
Example Interview Questions
Senior Level Questions
Q: How would you handle a major GMP deviation in production?
Expected Answer: A senior professional should explain the process of identifying the issue, implementing immediate corrective actions, conducting root cause analysis, documenting everything thoroughly, and developing preventive measures for the future. They should also mention the importance of possibly notifying regulatory authorities.
Q: How do you stay current with GMP regulations and implement changes?
Expected Answer: Should discuss monitoring FDA/regulatory updates, membership in professional organizations, regular training programs, and experience in implementing new requirements across an organization while maintaining production schedules.
Mid Level Questions
Q: What documentation is essential in GMP compliance?
Expected Answer: Should mention Standard Operating Procedures (SOPs), batch records, training records, equipment logs, and cleaning records. Should explain why proper documentation is important for tracking and proving compliance.
Q: How do you ensure staff follows GMP procedures?
Expected Answer: Should discuss training programs, regular audits, clear SOPs, monitoring systems, and how to build a quality-focused culture in the workplace.
Junior Level Questions
Q: What are the basic principles of GMP?
Expected Answer: Should be able to explain basic concepts like cleanliness, proper documentation, following procedures, and maintaining quality standards in simple terms.
Q: Why is documentation important in GMP?
Expected Answer: Should understand the basic principle that if something isn't documented, it didn't happen, and explain why keeping records is crucial for product quality and safety.
Experience Level Indicators
Junior (0-2 years)
- Basic understanding of GMP requirements
- Following SOPs and documentation practices
- Quality control basics
- Understanding of clean room procedures
Mid (2-5 years)
- GMP audit participation
- SOP writing and review
- Deviation investigation
- Training other staff on GMP procedures
Senior (5+ years)
- Leading GMP compliance programs
- Regulatory inspection management
- Quality system development
- Risk assessment and mitigation
Red Flags to Watch For
- No knowledge of basic GMP documentation requirements
- Lack of attention to detail in work history
- No understanding of quality control processes
- Unable to explain importance of following procedures
- No experience with regulatory compliance
Related Terms
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