Supply Chain Quality Manager
Ho Chi Minh, Viet Nam
2 ngày trước

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients.

Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

The main responsibility of the Supply Chain Quality (SCQ) Manager is accountable to establish and maintain an appropriate and sustainable Product Quality System and Quality Culture at the Pfizer Country Office (PCO) and FIE warehouse facility in order to ensure compliance with Pfizer, GMP / GDP / GSP and Regulatory Authority expectations.

The SCQ Manager shall ensure the Pfizer FIE warehouse complies wth Vietnam GSP. The SCQ Manager will also be responsible as the main point of contact for the investigation and resolution of all product quality issues discovered or originating in the PCO and for interacting with the relevant local stakeholders (such as Regulatory Affairs, Global Supply Chain (GSC), Medical, Commercial BU) and PGS on such issues.

The SCQ Manager will also monitor the product quality and compliance activities at the PCO, to ensure current regulatory expectations are met, and facilitate internal and regulatory GMP / GDP inspections and Vietnam GSP inspections for FIE warehouse.

The SCQ Manager will be accountable for the implementation and compliance to SCQ Functional and Global SOPs and any other Pfizer Quality Standard requirements as the primary contact point for business partners both internal and external.

SCQ Manager will also be accountable for the supply of compliant product into Vietnam market ensuring adherence to Good Manufacturing Practice / Good Distribution Practice for Medicinal Products and Good Storage Practice for FIE warehouse.

How You Will Achieve It

Development and Maintenance of Consistent Quality Culture

  • Provides ongoing education on Quality to relevant PCO functional groups, to increase awareness and understanding of requirements and enhance the Quality Culture.
  • Drive Stakeholder Value

  • Represent Quality Operations at relevant PCO and above market forums.
  • Provide Quality Operations input into projects, on-boarding of new contractors, new systems, business deals and new product launches.
  • Primary quality contact point for internal and external business partners.
  • Deviation Management

  • Lead cross-functional investigation team for deviations that occur within the responsibility of SCQ organization, agrees and tracks corrective / preventive actions.
  • Approve local deviation investigations raised by SCQ Specialist and monitor CAPA effectiveness checks.
  • Product Complaint management

  • Manages the intake and triage of complaints from the PCO in a timely manner, tracks complaint responses.
  • Review responses to complainant and ensure timely response to the complainant.
  • Ensure effective processes to meet all required complaint handling timelines and notification requirements.
  • Notification to Management

  • Informs SCQ Cluster Lead of significant deviations and complaints as well as any issues impacting marketed product within the required timeframes.
  • Lead Quality Review teams to ensure cross-functional input into issues
  • If required, attends Area Quality Review Teams (AQRT) meetings, as Market PCO representative, to provide the local perspective on the issue at hand.
  • Provides AQRT Executive Summary for issues originating under the responsibility of the PCO.

  • Implement the actions identified from Area Quality Review Team (AQRT) or Enhanced Quality Review Team (eSQRT) meetings, e.
  • g. recalls, communication with Regulatory Agency, local corrective / preventive actions

  • Lead local market action team and ensure effective completion of all required actions i.e. recall.
  • Product Quality System

  • Lead Implementation of SCQ Functional and Global SOPs and any other Pfizer Quality Standard requirements. This includes but is not limited to ensuring all relevant PCO colleagues are appropriately trained.
  • Report and review data and metrics on PCO quality performance and present in Management Quality Review.
  • Assess compliance of product quality systems & processes to identify improvement opportunities.
  • Lead the assessment of new quality system / local regulatory requirements and adjusts / enhances local quality systems and processes, when required.
  • Manage Quality Systems such as Commitment Tracking and Change Control. Ensure timely completion of actions.
  • Lead or participate inrisk assessment and apply Quality Risk Assessment tools as necessary.
  • Inspections and Internal Audit

  • Lead Self Inspection for SCQ scope of activities, issue Self Inspection report and agree the Corrective / Preventive actions with the auditee.
  • Lead preparation and facilitation of GMP / GDP related inspections of PCO by Regulatory Authorities or internal auditors.
  • Prepare and agree with SCQ Cluster Lead and the applicable PCO colleagues on responses and action plans to address issues identified during GMP / GDP related regulatory inspections or internal audits.
  • FIE warehouse

  • Lead Self Inspection for SCQ scope of activities for FIE warehouse, issue Self Inspection report and agree the Corrective / Preventive actions with the auditee
  • Lead preparation and facilitation of GSP related inspections of FIE warehouse by Vietnam Regulatory Authorities or internal auditors.
  • Prepare and agree with SCQ Cluster Lead and the applicable PCO and FIE warehouse colleagues on responses and action plans to address issues identified during GSP related regulatory inspections or internal audits.
  • Local Product Disposition

  • Performs local release of imported products, in compliance with the applicable local regulations and local procedures, prior to sale within country.
  • This includes temperature excursions resolution and compliance with registered details.

  • Performs evaluation and disposition of returned stocks according to Pfizer Quality Standard requirements
  • Ensure that Quarantine Alert Notices received are processed in a timely manner
  • Lead or perform risk assessment if required.
  • Ensure the system for release of imported products and evaluation of returned stocks is effective, efficient and compliant.
  • Repackaging and Relabeling

  • Ensures all operations are performed in compliance with Pfizer Quality Standard requirements.
  • Ensures Repackaging and Relabeling facility has been assessed and approved.
  • Approves the relevant Repackaging and Relabeling request forms for operations within scope of responsibility.
  • Ensure regulatory approval of the Repackaging and Relabeling activity is obtained, if required under the local regulations.
  • Ensure products are repacked / relabelled according to the repackaging / relabelling instruction with accurate documentation related to repackaging / relabeling operation and approved for release.
  • Local Contractor Quality Oversight (where managed by SCQ)

  • Ensure effective quality oversight of operations at contractors, which includes but is not limited to : Contractor Assessment and Approval : ensures all GxP contractors (including suppliers & service providers) have been formally assessed and approved.
  • Deviation Management : evaluates the impact of all significant deviations affecting Safety, identity, strength, purity & quality (SISPQ), generated at the contractor and agrees corrective / preventive actions.
  • If necessary, initiates the "Notification to Management" process.

  • Quality System Support : visits the contractor to assess quality systems, review quality performance and agree action plans to ensure continuous improvement.
  • Include quality reviews during Business Review Meeting (BRM).

  • Issue and review Metrics : Periodically assess the overall quality risk associated to the contractor. Act on adverse trends in order to improve contractor quality and compliance performance.
  • Develops, negotiates and maintains up to date Quality Agreements with GxP contractors involved in manufacture, relabeling / repackaging, laboratory testing or activities at Logistics Service Providers
  • Review quality performance and agree action plans to ensure continuous improvement.
  • Communicate regulatory inspection observations and RQA audit findings to SCQ Cluster Lead and provide input into CAPA plans
  • Facilitates Pfizer Regulatory Quality Assurance (RQA) audit process at the contractors. Define appropriate improvement, follow-up and communicate action closures.
  • Must-Have

  • A minimum of 5 years in the pharmaceutical industry in a quality role.
  • Must be a Vietnam Registered Pharmacist with valid pharmacy practice certificate and the scope of export and import of drugs
  • Demonstrated sound knowledge, solid experience and application in Quality Management system.
  • Demonstrated sound knowledge of current Good Manufacturing Practice / Good Distribution Practice / Vietnam Good Storage Practice.
  • Demonstrated sound knowledge and solid experience and application with Vietnamese regulations.
  • Ability to influence when necessary, particularly with stakeholders and external parties.
  • Ability to communicate across all levels of the organisation and also use communication to demonstrate the value of the quality organization.
  • Ability to interpret and analyze data with strong problem-solving skills to provide and support sound rationale to drive decision making.
  • Ability to act decisively.
  • Ability to challenge and see views from different perspective.
  • Ability to navigate complex situations
  • Knowledge of business acumen
  • Work Location Assignment : Flexible

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