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
