1、Quality Assurance & Inspections and Internal Audit
- Assists with the timely implementation of applicable quality management systems (SOPs) within the PCO.
- Assists with ensuring initial and continuous** **training programs are implemented and maintained for all relevant PCO colleagues.
- Ensures planned, permanent & temporary changes of GMP/GDP related activities & systems are managed & documented appropriately. Ensures change actions are completed as per agreed timelines.
- Collects key quality performance indicators, evaluates and highlights any significant trends and identifies actions.
- Monitor Key Performance Indicators (KPIs) of the QMS, evaluate and highlight significant trends, and identify actions. Leads and/or participates in Quality Review Meetings as required.
- Provides support in the preparation and coordination of any Health Authority (HA) inspection and/or internal Pfizer audits of GMP/GDP activities in the PCO.
- Work with local cross functional team to define appropriate action plans to address the inspection/audit observation and tracks action implementation within the agreed timelines.
- Participates in the self-inspection program as an auditor and/or auditee, as required.
- Leads and/or participates in the Quality Risk Management program for the consistent application, documentation and communication of risks to product quality/patient safety in support of GxP activities under the remit of SOQ.
2、Local Product Disposition & Resolution of Product Quality
- Perform the local release process of Products under the PCOs distribution license, as required.
- Supports the coordination of all Product repackaging and/or relabeling activities in the PCO and at the third-party packaging site. Review and approve documentation related to the repackaging and/or relabeling of Pfizer Product, as required.
- Actions Quarantine Alert Notifications promptly, as needed.
- Ensures quarantine shipments are managed compliantly according to procedures, as required.
- Provides support for any market action operation in the PCO, as required.
- Complaint Handling – Perform Intake and Triage, issue correspondence letter as required. Acts as a contact point for Regulatory Agency/reporter in the PCO, as required.
- Lead and/or participate in deviation investigations using appropriate tools and works with cross-functional teams to implement CAPAs.
- Notify Management of significant concerns or deviations within the QMS which have the potential to impact product, regardless of release status. Where issues originate in the PCO, assist with the preparation of QRT meetings, where required. Assist with the implementation of local actions identified during QRT.
- Management of relevant corrective and preventative actions (CAPA)
3、Supplier Quality Management
- Execute tasks associated with the management of GxP Suppliers including qualification, quality oversight in accordance with internal and regulatory requirements for GxP activities.
- Assists with ensuring appropriate customer screening processes are in place to align with Pfizer and local regulations, as required.
- Assist with the coordination of RQA audits at the Supplier.
4、Leadership Skills
- Facilitate development and execution of objectives / projects consistent with SOQ Purpose Blueprint.
- Development and Maintenance of Quality culture, within the team and organization.
5、Local Requirements
- Responsible for operation under GSP license.
- Responsible for IDC importation testing/surveillance testing.
- Responsible for Annual Product Report/Annual Product Quality Review Report completion as needed for regulation requirements.
- Support other required from local regulations.
**Here Is What You Need **(Minimum Requirements)
- A minimum Tertiary Education in Science, Pharmacy or related discipline.
- A minimum of 5 years in the pharmaceutical industry in a quality role
- Demonstrated ability to influence, when necessary, particularly with stakeholders and external parties.
- Experience in GSP and QMS.
- Technical writing and reporting
- Licensed Pharmacist is preferred
- Fluent in English (written & verbal)
**Bonus Points If You Have **(Preferred Requirements)
- Experience in quality administered systems
- Strong organizational skills and attention to detail
- Experience with regulatory compliance and documentation
- Ability to mentor and review the work of other colleagues
- Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Quality Assurance and Control