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 systems
* Assist with training programs as required
* Ensures planned, permanent & temporary changes of GMP/GDP related activities & systems are managed, documented appropriately & completed as per agreed timelines
* Monitors key quality performance indicators on quality performance, evaluates & highlights any significant trends and identifies actions, opportunities to propose improvements to the processes
* Provides on-going education on Quality to increase awareness & to enhance Quality Culture
* Lead and/or support the preparation and coordination of any Health Authority inspection and/or company internal audits of GxP activities
* Work with local cross functional teams to define appropriate action plans to address inspection/audit observations, tracking action implementation within the agreed timelines
* Ensures self-inspections are performed at defined intervals following a pre-arranged program
* Ensures 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 activities
* Responsible for the local release for distribution process
* Decides on the final disposition of returned, rejected, recalled or falsified products
* Manages Quarantine Alert Notifications promptly
* Ensures a compliant process is in place to manage quarantine shipments
* Ensures appropriate customer screening processes are in place to align with Pfizer and local regulations
* Coordinates & performs any market action operation promptly
* Responsible for Product repackaging and/or relabelling
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o Ensures deviations from Product Quality and Compliance requirements are investigated thoroughly, within required timelines
* Ensures that relevant customer complaints are dealt with effectively
* Notifies management of significant issues within the agreed timeline
* Management 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 parties
* Experience in Australian & New Zealand legislative requirements, GMP, GDP and QMS
* Technical writing and reporting
* A solid understanding of the regulatory and audit frameworks pertinent to biopharmaceutical operations
* Proficiency in taking decisive action based on quality and compliance metrics and trends
* Excellent interpersonal effectiveness, coupled with superior written and verbal communication skills
Bonus Points If You Have (Preferred Requirements):
* Experience in quality control and/or quality assurance within the pharmaceutical industry
* Experience in aseptic processes and operational knowledge
* Ability 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