Batch Record
A Batch Record is an important document used in pharmaceutical manufacturing that tracks every step of making medicine or medical products. Think of it like a detailed recipe book combined with a diary that records exactly what happened during production. It helps ensure that medicines are made the same way every time and meets strict safety rules. Companies must keep these records to show health authorities (like the FDA) that they're making products correctly and safely. This documentation is a key part of what's called "Good Manufacturing Practice" or GMP, which are the rules that pharmaceutical companies must follow.
Examples in Resumes
Created and reviewed Batch Records for new product lines
Supervised manufacturing team and ensured accurate completion of Batch Records and Manufacturing Batch Records
Led implementation of electronic Batch Record system, improving efficiency by 40%
Typical job title: "Batch Record Reviewers"
Also try searching for:
Where to Find Batch Record Reviewers
Professional Organizations
Job Boards
Professional Networks
Example Interview Questions
Senior Level Questions
Q: How would you handle a situation where you find a critical deviation in a batch record review?
Expected Answer: A senior reviewer should explain the process of documenting the deviation, assessing its impact on product quality, initiating investigation if needed, and working with manufacturing and quality teams to determine appropriate corrective actions.
Q: What experience do you have with implementing electronic batch record systems?
Expected Answer: Should discuss experience managing the transition from paper to electronic systems, training staff, validating the system, and ensuring compliance with regulations while improving efficiency.
Mid Level Questions
Q: What are the key elements you look for when reviewing a batch record?
Expected Answer: Should mention checking for completeness, accuracy, proper signatures/dates, correct calculations, any deviations, and ensuring all critical process parameters were met.
Q: How do you ensure data integrity in batch records?
Expected Answer: Should explain verification of proper documentation practices, checking for original entries, proper error corrections, no blank spaces, and ensuring all entries are contemporaneous.
Junior Level Questions
Q: What is the purpose of a batch record?
Expected Answer: Should explain that batch records document all steps in manufacturing a product, ensure consistency, and provide evidence of compliance with procedures and regulations.
Q: What do you do if you find an incomplete entry in a batch record?
Expected Answer: Should describe the proper procedure for identifying missing information, notifying appropriate personnel, and following up to ensure completion according to company procedures.
Experience Level Indicators
Junior (0-2 years)
- Basic understanding of GMP documentation
- Attention to detail in reviewing documents
- Knowledge of basic manufacturing documentation
- Understanding of documentation requirements
Mid (2-5 years)
- Thorough knowledge of batch record review process
- Experience with deviation management
- Understanding of regulatory requirements
- Ability to train others on documentation practices
Senior (5+ years)
- Implementation of electronic batch record systems
- Process improvement expertise
- Investigation and CAPA management
- Quality system optimization
Red Flags to Watch For
- Lack of attention to detail
- No understanding of GMP requirements
- Unable to explain documentation practices
- No experience with deviation management
- Poor communication skills
