Use Your Power for Purpose

Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, which is both science and risk-based, is designed to be flexible, innovative, and customer-oriented. Whether your role involves development, maintenance, compliance, or analysis through research programs, your contribution is crucial and will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a meaningful difference in the lives of those we serve.

What You Will Achieve

In this role, you will:

Ensure timely implementation of all applicable quality management systemsAssist with training programs as requiredEnsures planned, permanent & temporary changes of GMP/GDP related activities & systems are managed, documented appropriately & completed as per agreed timelinesMonitors key quality performance indicators on quality performance, evaluates & highlights any significant trends and identifies actions, opportunities to propose improvements to the processesProvides on-going education on Quality to increase awareness & to enhance Quality CultureLead and/or support the preparation and coordination of any Health Authority inspection and/or company internal audits of GxP activitiesWork with local cross functional teams to define appropriate action plans to address inspection/audit observations, tracking action implementation within the agreed timelinesEnsures self-inspections are performed at defined intervals following a pre-arranged programEnsures a Quality Risk Management program is in place for the consistent application, documentation and communication of risks to product quality/patient safety in support of GxP activitiesResponsible for the local release for distribution processDecides on the final disposition of returned, rejected, recalled or falsified productsManages Quarantine Alert Notifications promptlyEnsures a compliant process is in place to manage quarantine shipmentsEnsures appropriate customer screening processes are in place to align with Pfizer and local regulationsCoordinates & performs any market action operation promptlyResponsible for Product repackaging and/or relabelling.Ensures deviations from Product Quality and Compliance requirements are investigated thoroughly, within required timelinesEnsures that relevant customer complaints are dealt with effectivelyNotifies management of significant issues within the agreed timelineManagement of relevant corrective and preventative actions (CAPA).

Here Is What You Need (Minimum Requirements)

A minimum Tertiary Education in Science, Pharmacy or related discipline, with at least 7 years' experience in the pharmaceutical industry in a quality role.Demonstrated ability to influence, when necessary, particularly with stakeholders and external partiesExperience in Australian & New Zealand legislative requirements, GMP, GDP and QMSTechnical writing and reportingA solid understanding of the regulatory and audit frameworks pertinent to biopharmaceutical operationsProficiency in taking decisive action based on quality and compliance metrics and trendsExcellent interpersonal effectiveness, coupled with superior written and verbal communication skills

Bonus Points If You Have (Preferred Requirements):

Experience in aseptic processes and operational knowledgeAbility to adapt to changing priorities and manage multiple tasks simultaneously  
Work Location Assignment: Hybrid

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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