While the pharmaceutical industry continues to grow and evolve, GMP (Good Manufacturing Practice) compliance remains a top priority to ensure the safety and quality of products. Therefore, GMP is essential to every pharma manufacturing process to maintain compliance with pharmaceutical industry requirements.
One of the crucial steps to comply with those requirements is to implement an internal audit process and audit your processes. An internal audit team consisting of GMP internal auditor(s) who play a critical role in ensuring that GMP procedures are followed correctly within the organization.
In this article, we give you a quick overview of how to become a GMP certified auditor, and we've compiled a list of the essential soft skills for a GMP auditor. According to career experts, Zippia.com, 12.6% of auditor resumes contain excellent interpersonal skills, to cite one example of how important soft skills are for auditors.
Let's dive in and learn what skills a GMP internal auditor needs to become better and some tips you can work on improving.
How can I become a GMP certified auditor?
To become a GMP certified auditor, there is a series of technical skills you need to acquire first, including a relevant educational background, internal auditing certifications, and hands-on industry experience.
First of all, you need an educational background in science, engineering, or a related life sciences field. You will also need to develop technical expertise through industry experience in the area you want to audit, such as pharmaceutical, biotech, or medical device manufacturing.
You must be familiar with the GMP regulations and standards that apply to your sector and to the markets in which the organization operates, such as FDA, EMA, WHO, ISO, or ICH guidelines.
In addition, you need to complete formal training in GMP auditing principles and techniques and obtain certification from a recognized organization such as ASQ, RAPS, IRCA, or SQA. These courses and certifications help you develop the knowledge and skills required to plan, conduct, report on, and follow up on GMP audits. We have a GMP certification at the Scilife Academy that you can do to help you buildthe foundations.
However, technical skills alone are not enough to become an effective GMP auditor.
You should also develop strong soft skills to carry out your responsibilities effectively. These skills enable you to audit more efficiently, build solid relationships, and identify improvement opportunities. Developing soft skills takes time and effort, and it requires consistent practice.
But don’t worry, let’s dive into these key soft skills together!
Top Soft Skills for GMP Internal Auditors
1. Interpersonal Skills
As mentioned, one of the most significant skills of a successful auditor is excellent interpersonal skills, such as the ability to listen actively. The “80/20 rule” is named for the ideal ratio of listening time versus talking. You should spend 80% of your time listening and only 20% talking. Active listening that seeks understanding and comprehension has also proven invaluable in audit teams and the organization. In fact, “auditor” derives from the Latin words meaning “hearer” and “listener.”
If you want to stand out from other auditors, communication is the number one skill everyone seeks in an auditor. Successful auditors should have excellent internal and personal skills, not just listening to auditees all the time but also making auditees listen to themselves. Auditors demonstrate a high level of compliance knowledge and technical acumen. Auditees may have different levels of expertise and background. As a result, auditors share several traits regarding exceptional communication skills with different people. You need to be able to explain observations, findings, solutions, and complex technical information to others who might not have a pharma background. In other words, you need to clearly convey your thoughts, ideas, and suggestions during audits, meetings, and negotiations. This is for auditees, senior management, executives, and regulatory authorities.
Poor communication skills can lead to misunderstandings, ineffective recommendations, and a lack of trust between the auditor and the auditee.
To hone your communication skills, you can attend workshops, seminars, or training sessions on effective communication. You can also practice active listening, which involves fully concentrating on what the auditee is saying, asking open-ended questions, and paraphrasing to confirm understanding.
The stats back up the importance of communication skills. In a survey by Zippia.com, communication skills (66%) were ranked almost as vital as technology skills (67%) - making them one of the top two qualities auditors should possess.
2. Planning, Multitasking, and Time Management
No one can imagine an auditor without a plan or audit agenda.
Planning starts in advance once the audit is scheduled; then, you begin planning the audit day(s) by scheduling which processes will be audited and when.
Smaller companies build an internal audit team with existing employees. So, if you're in similar situations, you might have other duties and responsibilities along with the auditor role. You might work on multiple projects, even audits, simultaneously, and being organized with a strong sense of time management can help you ensure tasks get appropriately prioritized.
Most audits need to be conducted within tight deadlines, so you, as a GMP internal auditor, need to manage time effectively and efficiently. This is to ensure that all aspects of the audit are completed on time.
Poor time management can cause you to complete all audit aspects on time, potentially delaying necessary corrective actions and resulting in rushed or incomplete audits, leading to missed compliance issues.
Here are some tips to help you hone your time management skills.
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- Create a detailed audit plan.
- Set deadlines in advance.
- Prioritize tasks.
By doing those, use tools such as
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- Calendars,
- To-do lists,
- Task management apps,
- Reminders,
- Audit Management Software
3. Detail Oriented
GMP audit means examining each process to determine whether it meets GMP requirements. It requires a deep analysis of data derived from records, filled forms, or procedures. And it helps you discover potential compliance issues and ensure pharmaceutical products are safe and high-quality. Therefore, as a GMP compliance auditor, you should have a sharp eye for detail to identify potential product quality problems. It's a vital skill for GMP auditors, as a slight deviation from GMP requirements might have serious consequences, including recall and regulatory action. For this reason, you should determine such issues as early as possible and recommend possible corrective actions to the auditee in order to prevent them from occurring again.
It is possible to have serious consequences if you fail to identify potential compliance issues due to a lack of attention to detail. You may overlook critical issues, potentially leading to product recalls or other regulatory actions.
To hone your attention to detail skills, you can develop a systematic approach to auditing and follow a checklist. Additionally, you can take breaks during the audit to reduce fatigue and improve concentration.
4. Critical Thinking
Critical thinking involves different facets of analyzing and evaluating complex data and various situations. You need to think about all risks, ask the right questions and make observations. This can only be possible if you know enough about processes and GMP requirements. In other words, you need business acumen to do those activities perfectly.
It may not be enough to not only make observations and show what was missing; you should make a recommendation as to how the noncompliance can be resolved in the best way. Occasionally, if the problem is not common, you will need to explain it with similar cases and how you solved them. Additionally, this mindset can help you suggest compliant, efficient, and cost-effective solutions.
Critical thinking also plays a vital role in reviewing the closure report and actions undertaken. In order to evaluate whether the problem has been solved effectively, you need to visualize the situation and the steps taken to resolve it. Moreover, this skill helps you ask further questions regarding the actions undertaken and their evidence.
With this skill, you will earn the trust of executives, management, and auditees. This may bring you new opportunities within the company or job referrals.
You can follow the pieces of advice below to improve your critical thinking skills.
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- Practice analyzing complex data and identifying trends.
- Engage in brainstorming sessions with other auditors to exchange ideas.
- Practice thinking critically.
- Get feedback on your practice from experts.
5. Professional Skepticism
By having professional skepticism, you show more strength of character to avoid shortcuts and reexamine all facets of the audit. During an audit, you should always ask yourself if the data or records shown are valid. You should always be skeptical about each piece of evidence and carefully evaluate everything for assurance. Additionally, remain objective and constructive while observing and asking further questions. This attitude also makes you a reliable, ethical, and successful auditor.
Professional skepticism is somewhere between complete trust and complete doubt. Either way, it is not acceptable for a successful auditor.
To hone your professional skepticism skills, you can:
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- Utilize a sound judgment process and exercise sound judgment.
- Make sure to take into account all relevant information and consider different perspectives.
- Be open to new ideas and make decisions based on facts, not assumptions.
- Avoid biases and judgment traps.
6. Empathy
Empathy allows an auditor to understand the client's perspective better as the audit operation progresses.
Understanding auditees' perspectives and concerns can help build rapport and improve the effectiveness of the audit process. Empathy can help auditors build trust with auditees and strengthen cooperation during the audit process.
Building rapport and trust with auditees requires empathy. GMP internal auditors who possess empathy can create a positive audit experience and obtain the necessary information to conduct the audit effectively.
A lack of empathy may come across as overly critical or dismissive, potentially damaging the relationship between the auditor and the auditee. This can make obtaining the necessary information to conduct an audit more challenging.
You can put yourself in the auditee's shoes to hone your empathy skills and understand their perspective. Also, you can build rapport by engaging in small talk and showing genuine interest in the auditee's work.
7. Integrity
Integrity is another quality of an ethical GMP auditor, and it's critical to uphold your personal and professional integrity. For example, you might conduct an audit and issue a solutions report that a company executive finds displeasing. If you were asked to change the report on compensation, you would compromise your integrity by agreeing. However, if you turn down the offer, you uphold both your integrity and the audit.
Scilife supports smoother internal GMP audits by standardizing audit workflows, centralizing documentation, and ensuring findings and CAPAs are easy to track and verify. You can see how our audit management software can support you here.
How to improve those auditing skills
We've already suggested some tips for each skill, but check these general recommendations on how you can improve your auditing skills:
1. Professional feedback
By knowing your strengths and weaknesses, you will be able to focus on developing the skills you need. Ask a colleague or leader for open and honest feedback about what you do well and where you can improve. The information provided by others is often valuable.
2. Experience
As a GMP auditor, you hone and develop your skills as you gain practice and experience. You may want to consider taking related jobs in the pharmaceutical field if you wish to gain more experience in auditing positions. It is also possible to volunteer your time and expertise to organizations, helping them review and analyze their systems and making recommendations to increase your skill set. Your resume may also benefit from including volunteer opportunities.
3. Professional organizations
Become a member of an industry club, association, or organization to enhance your professional development. You can grow your skills by joining groups, taking training, attending conferences, and attending other learning opportunities. They also help you stay up to date on auditing news, techniques, and studies. Becoming a member of industry groups can also enable you to grow your professional network, learn about career opportunities, or gain mentors.
4. Mentorship
Every professional benefits from having a mentor, and as a GMP auditor, you can gain the knowledge and experience you need to progress. Look for a mentor who shares your goals or ideals, has significant industry experience, and is someone you admire. An effective mentor often has the following qualities:
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- A passion for teaching others
- A passion for their profession
- Professionalism and respect
- An eagerness to see others succeed
- Ability to communicate and provide feedback
- An empathic listening ability
- Willingness to be a mentor
- Ability to mentor effectively
To improve your soft skills, you can attend workshops, seminars, or training sessions on effective communication, develop a systematic approach to auditing, practice analyzing complex data and identifying trends, create a detailed audit plan, prioritize tasks, and build rapport with auditees.
Conclusion
Becoming a successful GMP internal auditor requires a combination of technical expertise and soft skills. Interpersonal skills, planning, multitasking, time management, attention to detail, critical thinking, professional skepticism, and empathy are just a few of the soft skills that can make a huge difference to the auditor's effectiveness. While regulatory knowledge, technical expertise, risk management, data analysis, and audit techniques are key technical skills for the role.
By improving these skills, you can ensure pharmaceutical products' safety and quality. In addition, you can contribute to the continuous improvement of GMP compliance within the industry. It's worthwhile to note that these skills can be developed and enhanced over time through training, practice, and experience. This will enable you to stay up to date with changing regulations, new technologies, and evolving best practices. By doing so, they can improve audit effectiveness and add value to their organizations.
Discover how a Smart QMS can help you prepare and carry out internal audits successfully!
