Quality Auditor - Pharmaceutical - job 1 of 2

As a Quality Auditor at SQA, your primary responsibilities will include conducting detailed quality audits of suppliers for our various clients within the pharmaceutical and life sciences sectors. You’ll collaborate with the operations team to schedule and execute audits, and ensure that findings are integrated into client risk management processes. Your expertise in GMP regulations and manufacturing will be crucial in tailoring audit processes to meet client-specific needs and expectations.

To qualify for the Quality Auditor position at SQA, applicants need at least four years of relevant experience in auditing, particularly in APIs, Excipients, or related manufacturing processes. Knowledge of GMP regulations in the life sciences industry is essential, along with familiarity with specific regulatory frameworks such as 21CFR regulations. Candidates must also be strong communicators in English and should be prepared for regional travel.

SQA offers a competitive pay range of $1000 to $1200 per day for Quality Auditors, which includes all activities such as preparation, travel, and performance of the audit, as well as report writing and client communication. This dynamic compensation reflects the expertise and critical role that auditors play in ensuring quality and compliance for our clients.

The audit process for a Quality Auditor at SQA involves several key steps: coordinating with clients to understand their unique audit needs, preparing comprehensive checklists, conducting on-site audits, and evaluating suppliers against GMP regulations. Post-audit, you are responsible for drafting detailed reports that reflect your findings, which will then be communicated to the clients with clarity and professionalism.

Travel is an important component of the Quality Auditor role at SQA. You will be expected to visit supplier sites to perform audits, which may require regional travel. Flexibility and a readiness to travel are vital since the nature of this role involves on-site evaluations to ensure client standards are consistently met and adhered to.

Communicate your past experiences clearly, highlighting specific audits you’ve conducted and the regulatory frameworks you’re familiar with, such as GMP. Use examples to showcase your ability to identify compliance gaps and how you resolved them, emphasizing your attention to detail and adherence to industry standards.

Outline your preparation strategy, which may include reviewing audit checklists, examining prior audit reports, and understanding the supplier’s processes and systems. Mention the importance of researching relevant regulations and any specific client requirements to ensure a smooth and effective audit process.

Discuss your approach to drafting audit reports, ensuring clarity and precision. Emphasize your ability to tailor communication to both technical and non-technical stakeholders, using layman’s terms when necessary to ensure comprehension while maintaining professionalism throughout the process.

Provide examples of specific challenges, such as pushback from suppliers or issues in data access. Describe the solutions you employed, such as fostering collaborative relationships or implementing clear communication to resolve misunderstandings and keep the audit process on track.

Share your familiarity with GMP regulations, emphasizing both practical understanding and how you’ve applied these regulations during your audits. Mention any certifications or training you've completed that bolster your knowledge in this area to convey your authority on the topic.

Narrate a specific instance where you spotted a serious non-conformance during an audit, how you documented it, and the steps you took to ensure it was addressed. Illustrate your analytical skills and commitment to compliance by discussing the outcomes that followed and any improvements made.

Mention any audit management software, checklists, or reporting tools that you regularly utilize to streamline the audit process. Discuss the benefits of these tools in organizing data, enhancing communication, and ensuring thorough documentation of findings for future reference.

Explain your strategies for keeping current with industry regulations, such as attending webinars, participating in training courses, reading industry-related publications, and engaging with professional networks. Highlight how this continuous learning contributes to your effectiveness as an auditor.

Talk about your ability to maintain composure during stressful situations by prioritizing tasks, utilizing time management skills, and fostering a collaborative environment with suppliers. Share techniques such as deep breathing or taking short breaks to ensure that you remain effective throughout the audit.

Express your passion for quality assurance and your desire to work with leading pharmaceutical companies to ensure compliance and safety. Tie your motivations to SQA's reputation for excellence and your enthusiasm to contribute positively to their mission and the well-being of patients.