The SOQ Senior Associate will be responsible for supporting, maintaining, and implementing the Quality Management System (QMS) at the Pfizer Country Offices (PCOs) to ensure compliance with both Pfizer and Regulatory Authority expectations.
The SOQ Senior Associate will work closely with relevant local stakeholders, such as Global Regulatory Sciences (GRS), Global Supply Chain (GSC), Medical, and PGS sites or ESOQ to ensure that the appropriate quality standards and systems are implemented and maintained for the product supply operation of the Pfizer Vietnam business.
The SOQ Senior Associate is appointed as the Chief Pharmacist or to manage delegated duties of Chief Pharmacist for Vietnam Good Storage Practice License
- 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.
- Assists planned, permanent & temporary changes of GMP/GSP 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.
- Assists in the monitoring of 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/GSP 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.
- 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.
- Assists in the local release process of Products under the PCOs distribution licence, as required
- Supports the coordination of all Product repackaging and/or relabelling activities in the PCO and at the third-party packaging site. Review and approve documentation related to the repackaging and/or relabelling of Pfizer Product, as required.
- Assists in 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, assist in the issuance of correspondence letter as required. Acts as a contact point for Regulatory Agency/reporter in the PCO, as required.
- 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.
- Assists in the Management of relevant corrective and preventative actions (CAPA)
- 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.
- Assists in the development and execution of objectives / projects consistent with SOQ Purpose Blueprint.
- Assists in the development and Maintenance of Quality culture, within the team and organisation.
JOB REQUIREMENTS
- A minimum Tertiary Education in Pharmacy
- 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 Vietnam Pharmacy Law 2016, GMP, GDP, Vietnam GSP and QMS.
- Technical writing and reporting
- Registered Pharmacist with Vietnam Pharmacy Board with a valid pharmacy practice certificate (“chứng chỉ hành nghề dược”) and the scope of export and import, storage service of pharmaceuticals and/or vaccines
- Fluent in English (written & verbal) – business proficiency
- Fluent in Vietnam (written & verbal) – business proficiency
- Experience in Quality administered systems.
- Excellent computer system skills – Word and Excel essential.
- Experience with electronic documentation control systems advantageous.
- Previous use of Trackwise®, eQMS beneficial.
Work Location Assignment: Hybrid
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Quality Assurance and Control