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SOQ Internal Auditor

Use Your Power for Purpose

Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are involved in development, maintenance, compliance, or analysis through research programs, your contribution directly impacts patients.  

What You Will Achieve

In this role, you will be part of a SOQ Compliance Team responsible for leading the execution of Self-Inspections (internal audits) across all SOQ locations with manufacturing and distribution licenses (EU Release, GLNS, distribution centers, markets), according to the Pfizer Internal Audit process and applicable GMP and GDP requirements, aiming to assess the effectiveness of the Quality Management System and ensure compliance with the applicable regulatory requirements accross the SOQ locations.

Main tasks:

  • Perform and document the Risk Assessment for each SOQ location to be audited – define the business activities, identify audit scope, determine the audit focus areas

  • Audit preparation – determine duration, obtain agreement on the audit date, complete audit agenda

  • Audit execution – conduct the opening meeting, the audit and the closing meeting

  • Audit report writing and finding classification – write the audit summary, write and classify each audit finding

  • Review and accept the finding response

  • Review and accept the finding response

  • Member of the PGS Community of Practices for Internal Audits, to ensure continuous improvement and learning possibilites.

Here Is What You Need (Minimum Requirements)

  • Education: A Bachelor’s Degree in Natural Sciences

  • Experience: A minimum of 4 years previous experience in GMP/GDP Quality Operations, preferably within the Quality and/or Compliance fields. 

  • In depth knowledge of GMP, GDP, medical devices legal requirementt and Pfizer Quality Standards

  • Languages: Fluent in English (spoken and written)

  • Computer skills: Electronic systems literacy – Microsoft Office tools, PDOCS, PLA, QTS, eQMS, SAP

  • Scientific knowledge and strong analytical skills to make sound quality decisions, ability to corelate and integrate all applicable GMP and GDP concepts

  • Ability to communicate effectively verbally and in writing, good negotiation and influencing skills

  • Strong Quality technical writing skills and presentation skills

Bonus Points If You Have (Preferred Requirements)

  • Auditor background is preferred

  • Time management, planning and organization skills, ability to work under minimal supervision and in a team

  • Dynamic, flexible, enthusiastic and eager to learn

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Flexibility to work in different time zones

Virtual Self-Inspections for ERS, GLNS, markets; on-site or virtual Self-Inspections for Distribution Centers

  
Work Location Assignment: On Premise

At Pfizer we care about our colleagues’ wellbeing and offer a range of great benefits for them, including:

  • Paid parental leave

  • Access to Health & Wellness apps

  • Career Growth Experiences program

  • Recognition & rewards program

  • Paid volunteer days

  • Life Insurance Benefits

  • Pfizer Learning Academy access to top content providers

  • Access to flu vaccines & skin checks

  • Options to purchase additional leave

  • Salary packaging & novated lease options

*Benefits listed may vary depending on your position and location and may be subject to change.

Pfizer Australia and New Zealand’s diverse workforce represents the patients we serve and the communities in which we operate. With a focus on Diversity, Equity & Inclusion (DE&I), Pfizer ANZ ensures our people are heard and cared for. We offer engagement opportunities in both Colleagues Resource Groups (CRGs) and workstreams across: Culture and Tradition, Reconciliation @ Pfizer (RAP), Gender Equity (GEN), Disability and through the Out Pfizer Employee Network (OPEN) for our LGBT + colleagues and allies.

If you require reasonable adjustment during your application, please reach out to the Talent Acquisition Manager.


Quality Assurance and Control


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What You Should Know About SOQ Internal Auditor, Pfizer

At Pfizer, we are on a mission to improve the quality of life for patients every day, and we need a dedicated SOQ Internal Auditor to help us achieve this goal. Based in Mulgrave, Victoria, this role is a fantastic opportunity for someone who thrives in a flexible and innovative environment. As a crucial member of our SOQ Compliance Team, your innovative spirit will play a vital role in leading internal audits across all our SOQ locations, ensuring compliance with both GMP and GDP requirements. You will conduct comprehensive Risk Assessments, prepare thoroughly for audits, and gather insights to continually improve our Quality Management System. If you have a background in Quality Operations and a passion for enhancing patient care through quality assurance, your expertise will be invaluable. From writing detailed audit reports to connecting with various teams within Pfizer, you will ensure we meet and exceed industry standards. Are you ready to make a difference and leverage your experience to contribute to our steadfast commitment to safety and efficacy? Join us at Pfizer, where your skills and dedication will help shape the future of healthcare. Your journey starts here, and together we can make an impactful change!

Frequently Asked Questions (FAQs) for SOQ Internal Auditor Role at Pfizer
What are the primary responsibilities of the SOQ Internal Auditor at Pfizer?

As a SOQ Internal Auditor at Pfizer, you'll be involved in leading internal audits across our various SOQ locations. Key responsibilities include conducting Risk Assessments, preparing audit agendas, executing audits, documenting findings, and writing comprehensive audit reports. You'll also take part in the PGS Community of Practices, which focuses on continuous improvement and learning within the organization.

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What qualifications are needed to apply for the SOQ Internal Auditor position at Pfizer?

To apply for the SOQ Internal Auditor role at Pfizer, a Bachelor's Degree in Natural Sciences is required along with at least 4 years of experience in GMP/GDP Quality Operations. Familiarity with Pfizer's Quality Standards and knowledge of regulatory requirements are essential for this position.

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How does Pfizer support career growth for SOQ Internal Auditors?

Pfizer is committed to the professional development of its employees, including SOQ Internal Auditors. Our company offers various growth experiences, learning programs, and access to top content providers through the Pfizer Learning Academy. This initiative empowers our auditors to enhance their skills and advance their careers within the organization.

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What skills are essential for a successful SOQ Internal Auditor at Pfizer?

A successful SOQ Internal Auditor at Pfizer should possess strong analytical skills, effective communication abilities, and proficiency in technical writing. Additionally, familiarity with electronic systems such as Microsoft Office, PDOCS, and SAP are crucial, along with the capacity to work under minimal supervision and within a collaborative team environment.

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What benefits does Pfizer offer to SOQ Internal Auditors?

Pfizer offers a comprehensive benefits package to SOQ Internal Auditors, including paid parental leave, access to health and wellness apps, a recognition and rewards program, and various insurance benefits. Additionally, employees have the opportunity to participate in volunteer days and access career growth programs, demonstrating our commitment to the well-being of our team.

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Common Interview Questions for SOQ Internal Auditor
Can you explain the significance of conducting Risk Assessments as a SOQ Internal Auditor?

Conducting Risk Assessments is crucial as it helps identify the business activities that require auditing and establishes the focus areas necessary for evaluating compliance with GMP and GDP. Demonstrating an understanding of how to effectively assess risk will show your preparedness for the role.

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How do you prepare for an internal audit?

Preparing for an internal audit involves coordinating with relevant stakeholders to determine the audit timeline, understanding the audit scope, and developing an agenda. Demonstrating your ability to plan thoroughly will reflect your organization skills and readiness for the role.

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What is your experience with GMP and GDP regulations?

Articulating your knowledge and experience with GMP and GDP will highlight your qualifications. Discuss your previous roles where you ensured compliance and your strategies for staying updated with regulatory requirements.

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Describe how you classify audit findings.

Classifying audit findings involves determining their severity and impact on compliance. Explain the criteria you use to classify findings and any past experiences where your classification helped improve the quality system.

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How do you approach writing an audit report?

When writing an audit report, structuring your findings clearly and logically is key. Discuss how you ensure your reports are comprehensive and adhere to company standards for technical writing, which is essential for clear communication.

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What strategies do you use to ensure effective communication during audits?

Effective communication during audits involves being concise, clear, and maintaining a respectful tone. Mention your techniques for engaging with stakeholders and facilitating open dialogue to promote a positive audit experience.

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Can you provide an example of a time you improved a process based on audit findings?

Storytelling is effective here. Share a specific instance where you identified a process inefficiency and how implementing changes based on audit findings led to measurable improvements in compliance or efficiency.

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How do you handle disagreements with team members regarding audit findings?

Handling disagreements effectively is vital. Discuss techniques like active listening, maintaining professionalism, and emphasizing the common goal of regulatory compliance to resolve conflicts amicably.

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What role does continuous improvement play in the work of a SOQ Internal Auditor?

Continuous improvement is at the heart of quality auditing. Articulate how embracing this mindset not only enhances audit processes but also contributes to maintaining high standards of patient safety and product efficacy.

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Why do you want to work at Pfizer as a SOQ Internal Auditor?

Reflecting on your motivations for joining Pfizer can add a personal touch. Mention Pfizer’s commitment to quality and patient care, alongside your desire to grow within a progressive and supportive environment.

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April 7, 2025

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