How to Become a GMP Quality Auditor?

In today’s pharmaceutical industry, many professionals aspire to become GMP (Good Manufacturing Practice) auditors. However, many of these individuals, particularly those from departments such as QC, Production, or R&D, are often unsure about how to transition into this role. This guide aims to provide detailed insights on how you can become a GMP auditor, regardless of your current department.

In today's scenario, the majority of experienced pharmaceutical professionals aspire to work as quality auditors and conduct GMP audits, but they lack the necessary guidance or knowledge to do so. Even though a large number of experienced professionals from all departments has strong knowledge and expertise in their respective fields, they are aware that only QA experts are qualified to conduct GMP audits.

Can Non-QA Professionals Become GMP Auditors?

Absolutely! While many believe that only those in the QA (Quality Assurance) department can audit, professionals from various departments, such as QC, R&D, or Production, can also become GMP auditors. The key is acquiring deep knowledge of the Quality Management System (QMS), GMP guidelines, and process flows.

How to Become a GMP Auditor for Experienced QA Professionals?

If you're already working in QA, you have an advantage. QA professionals have access to master documents and regularly interact with different aspects of quality management. However, larger pharmaceutical companies often have segmented QA roles, limiting exposure to other QA activities. Here’s how you can grow into a GMP auditor:

Steps to Becoming a GMP Auditor:

1. Expand Your Responsibilities: Request opportunities to learn beyond your routine tasks. Whether it’s through job rotation or exposure to other QA functions, broadening your skill set is essential.
2. Switch to a Smaller Organization: Smaller or mid-sized companies often provide broader QA roles, allowing you to gain hands-on experience with a wider range of processes.
3. Self-Learning: Constantly update yourself with plant activities, SOPs, and external guidelines. Attend on-the-job and external training sessions to grow your knowledge.
4. Start with Internal Audits: Begin by participating in internal audits. This will enhance your confidence and document review abilities. The more you audit internally, the better prepared you’ll be for vendor audits.
5. Take on Vendor Audits: Once you’ve gained internal auditing experience, seek out vendor auditing opportunities for raw materials or packaging. This will require you to plan audits, interact with vendors, and conduct thorough reviews.
6. Prepare Thorough Reports: Post-audit, ensure you prepare detailed audit reports, categorize observations, and recommend necessary actions. Following up on compliance is crucial to maintaining audit integrity.
7. Pursue Certification: After gaining practical experience, consider pursuing certification programs like the Certified Quality Auditor training from institutes such as IRCA, NSF Pharma, or ASQ. Classroom-based training is recommended for deeper learning.

Key Points for QA Professionals:

• Always stay updated on regulatory guidelines.
• Focus on enhancing both your technical and professional skills to become an effective auditor.
• Build leadership qualities to manage cross-functional teams during audits.

ALSO READ: GMP Audit Checklist for Pharmaceutical Industry

How to Become a GMP Auditor for Professionals from Non-QA Departments?

Approximately 80% of professionals from non-QA departments are interested in transitioning to QA roles. However, becoming a GMP auditor from a non-QA background requires more effort, as QA roles involve a deep understanding of regulatory requirements and quality systems. If you’re willing to put in the work, here’s how you can make the switch:

Steps to Transition into QA and Become a GMP Auditor:

1. Gain Knowledge on QA Operations: Start by self-learning or attending cross-departmental training on QA functions. Understanding SOPs, regulatory guidelines, and the entire quality system is critical.
2. Request Internal Transfers: If possible, request a transfer to QA within your current organization. Smaller organizations often offer greater learning opportunities in QA functions.
3. Develop Regulatory Knowledge: Keep yourself updated with regulatory guidelines, attend training sessions, and read extensively on QMS.
4. Take Part in GMP Training Programs: Companies often provide GMP training, even for non-QA professionals. Attend these to develop a foundational understanding of QA principles.
5. Become a Good Internal Auditor: Like QA professionals, you should start with internal audits to build confidence. Follow the steps for internal auditing outlined earlier, gradually working toward vendor audits.

Overcoming Challenges:

• Transitioning from departments like QC, R&D, or Production to QA can be tough. However, with hard work, self-study, and training, you can overcome these challenges.
• The process is the same as for QA professionals: take on internal audits, progress to vendor audits, and eventually pursue certification.

ALSO READ: Checklist for Internal Quality Auditing

Essential Skills for Becoming a Successful GMP Auditor

No matter your background, a successful GMP auditor must possess certain core skills:

1. Deep Regulatory Knowledge and Continuous Learning

A smart QA auditor possesses an in-depth understanding of the pharmaceutical industry's regulatory landscape. This goes beyond memorizing regulations; it involves interpreting them correctly and staying updated with changes. Continuous learning is vital. Subscribe to industry publications, attend seminars, and participate in webinars.

2. Critical Thinking and Analytical Skills

Smart QA auditors excel at critical thinking and problem-solving. They don’t just identify issues; they analyze them to understand root causes and potential impacts. Develop your analytical skills by practicing root cause analysis techniques and engaging in exercises that challenge your problem-solving abilities. Always ask the “why” behind every finding to uncover deeper insights.

3. Effective Communication Skills

Effective communication is essential for a QA auditor. Sharpen your communication skills by learning to present complex information in a straightforward manner. Engage in active listening during audits and discussions, ensuring you understand and can articulate both the issues and solutions effectively.

4. Technological Proficiency

The pharmaceutical industry is increasingly leveraging technology to enhance quality assurance processes. Familiarize yourself with the latest QA tools and software. Embrace technology to streamline your auditing process and improve accuracy.

5. Proactive Risk Management

A smart QA auditor anticipates potential issues before they become significant problems. Develop your risk management skills by understanding the principles of risk assessment and learning to apply them effectively in your audits.

6. Leadership and Team Collaboration

Smart QA auditors often play a leadership role, guiding teams through complex quality issues. Develop leadership skills by taking on more responsibilities, seeking feedback, and learning from mentors. Collaboration with other departments is crucial; it ensures a holistic approach to quality assurance.

7. Attention to Detail and Thorough Documentation

Attention to detail is non-negotiable in QA auditing. Practice thorough documentation and attention to detail in all your work. Use checklists, but don’t rely on them entirely. Instead, understand the underlying principles and ensure your audits are comprehensive and detailed.

Carefully review the following points: 

• Assume responsibility only once you are completely comfortable handling it and have a thorough understanding of the systems and regulations involved.
• Because you might have to interact with people who are more senior and have more experience than you during an audit.
• You must be able to respond to all enquiries as an auditor using regulatory references.
• A regular reading schedule and self-awareness are essential for auditors.

• Being impartial by nature, an auditor should solely consider patient safety and product quality.
• Although auditors gain knowledge from their experiences and trainings, their confidence and aptitude at the beginning of their careers only serve to further their auditing profession.
• An auditor must maintain objectivity and always convey to management, regulatory bodies, or clients the actual audit report and their operational reality.
• American Society for Quality's (ASQ) Certified Quality Auditor training program for anybody interested in becoming a Certified Quality Auditor. As an auditor, patient safety and product quality are your top priorities.

Conclusion

Becoming a GMP auditor requires dedication, knowledge, and the right approach. Whether you're from QA or another department, the key is continuous learning, effective communication, and the ability to handle responsibility. With perseverance, anyone can transition into a GMP auditing role, contributing to product quality and patient safety.

Investing time in learning, certification, and skill-building will not only boost your career but also strengthen the pharmaceutical industry’s commitment to quality.

ALSO READ: SOP for Internal Audit