Defines Auditing as under: “Auditing is a systematic and independent examination of data,

statements, records, Operations and performance (financial or otherwise) of an enterprise for a

stated purpose. In any auditing situation, the auditor perceives and recognizes the propositions
before him for examination, collects evidences, evaluates the same and on this basis, formulates his
judgment which is communicated through his audit report”. Key phrases in the above definition are :
i) Independent ii) Systematic iii) Data, statements, records operations and performance iv) Specific
purpose v) Perceives and recognizes the propositions before him for examination vi) Collects
evidence, evaluates the same vii) Formulates his judgment which is communicated through his audit
report

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.

Create a detailed audit plan.

Set deadlines in advance.

Prioritize tasks.

By doing those, use tools such as

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.

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:

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.

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:

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.