Pfizer
pharmaceutical
SupplyOperationsQualityMarketManager
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“Supply Operations Quality Market Manager at Pfizer. Skills: Quality management, Regulatory compliance, Audit coordination. Ensure timely implementation of quality management systems. Assist with training programs”
What You'll Achieve.
Deliver safe and effective products to patients; Meet highest standards of quality and safety
Industry & Context.
What They're Looking For.
Must Have
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 You'll Do.
Ensure timely implementation of quality management systems
Assist with training programs
Manage GMP/GDP related activities & systems
Monitor key quality performance indicators
Provide education on Quality
Lead/support Health Authority inspection preparation
Coordinate company internal audits
Work with local cross functional teams
Ensure self-inspections are performed
Ensure Quality Risk Management program is in place
Responsible for local release for distribution
Decide on final disposition of returned products
Manage Quarantine Alert Notifications
Ensure compliant process for quarantine shipments
Ensure appropriate customer screening processes
Coordinate market action operations
Responsible for Product repackaging
Responsible for Product relabelling
Ensure deviations are investigated
Ensure customer complaints dealt with
Notify management of significant issues
Management of corrective and preventative actions
How You'll Work.
Team & Collaboration
Work with local cross functional teams to define action plans
Communication Scope
Superior written and verbal communication skills
Full Job Description
**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
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