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
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.
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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!
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