This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
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.
Job Responsibility:
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
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)
Requirements:
A minimum Tertiary Education in Science, Pharmacy or related discipline
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
Nice to have:
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
What we offer:
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