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Pfizer () Quality Responsible Person (Q in Tokyo, Japan

ROLE PURPOSE

  • The key role of the Q-RP is to establish and maintain an appropriate and sustainable Quality Management System and Quality Culture within the Pfizer Country Office (PCO) in order to ensure compliance with Pfizer and Regulatory Authority expectations.

  • Q-RP is the Quality Responsible Person related to distribution activities, focusing on the management of authorized activities and the accuracy and quality of records.

  • Q-RP is the main point of contact for the investigation and resolution of all product quality issues detected or originating in the PCO and for interacting with the relevant local stakeholders (such as Regulatory Affairs, Medical, Business Units) and Pfizer Global Supply (PGS) on such issues.

  • Q-RP monitors the product quality and compliance activities within the PCO, to ensure current regulatory expectations are met, and facilitate internal and regulatory GMP/GQP/GDP inspections.

KEY ACCOUNTABILITIES

1. Resolution of Product Quality and Compliance Issues

Deviation Management (in conjunction with the PGS Quality Operations):

Investigates, together with appropriate local functions, deviations from Product Quality and Compliance requirements that occur within the responsibility of the PCO and agrees and tracks preventive/corrective actions. Local investigations may relate to product damage, artwork and labeling errors, counterfeits, temperature excursions during transport or issues with contract manufacturers or logistics service providers etc.

Customer Complaints handling:

Ensures that relevant customer complaints are dealt with effectively.

Manages the intake and triage of product quality complaints from the local market, assigns class and criticality to the product complaint and forwards them to the appropriate investigating PGS/Contractor Site via the global complaints management system.

Tracks responses to product quality complaints. Develops and issues responses to complainants in a timely manner, if requested.

Provides input form quality perspective to Commercial Department for the resolution of customer complaints related to distribution activities.

Notification to Management:

Informs PGS Quality Operations Management of significant deviations and complaints.

Attends Area Quality Review Teams (AQRT) meetings, as relevant PCO representative and provides the local perspective on the issue at hand. Provides AQRT Executive Summary Report for issues originating under the responsibility of the PCO.

Ensures the local implementation of actions identified during AQRT meetings, e.g. recalls, communication with Regulatory Agency, local corrective/preventive actions.

2.Quality Management System

Ensures timely implementation of all applicable Product Quality SOPs (issued by SCQ) within the PCO. Ensures that initial and continuous training programs are implemented and maintained for all relevant PCO colleagues. Monitors key quality performance indicators, evaluates and highlights any significant trends and identifies actions. Ensures that self-inspections are performed at appropriate regular intervals following a pre-arranged program and necessary corrective measures are put in place. Assesses new quality system/local regulatory requirements and adjusts/enhances local systems and processes when required. Ensures that any additional requirements imposed on certain products by national law are adhered to. Keeps appropriate records of any delegated duties.

3.Local Product Disposition

Responsible for the local release of products under the distribution license of PCO, in compliance with the applicable local regulations and local procedures, prior to distribution/sale within country. Decides on the final disposition of returned, rejected, recalled or falsified products.

Defines requirements under which returns can be taken back to saleable stock and supports local actions, in cooperation with logistics and distribution center.

Coordinates and promptly performs any recall operations for medicinal products.

Initiates the required actions if counterfeit products are identified.

4.Inspections and Internal Audit

Supports the Responsible Person (RP) in the preparation and coordination of GMP/GQP/GDP Regulatory Agency inspections. Supports preparation and coordination of [Regulatory Agency inspections and, as applicable] internal Pfizer audits of Product Quality and Compliance (GMP/GQP/GDP) activities at the PCO. Works with local functions to define an appropriate action plan to address the inspection/audit observation. Tracks the implementation of the identified actions within agreed timeframes.

5.Subcontracted activities with GMP/GQP/GDP impact

Approves any subcontracted activities which may have an impact on GMP/GQP/GDP: Develops, negotiates and maintains up to date Quality Agreements with GMP/GQP/GDP contractors, e.g. Logistics Service Providers (LSPs), relabeling/repackaging contractors. Oversees quality operations at contractors, which includes but is not limited to:

Contractor Assessment and Approval: ensures all GMP/GQP/GDP contractors have been formally assessed and approved.

Deviation Management: evaluates the impact of all significant deviations affecting safety, identity, strength, purity and quality, generated at the contractor and agrees corrective 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.

Issue and review Metrics: periodically assesses the overall quality risk associated to the contractor. Acts on adverse trends in order to improve contractor quality and compliance performance.

Facilitates the Pfizer Manufacturing Supplier Quality Assessment audit process at the contractor. Helps to define action plans for improvement and follow-up and communicate action closures.

6.Quarantine Alert Notices

Receives and manages Quarantine Alert Notices received from Primary Logistic locations. Establishes if product lots remains at LSP and, if so, alerts the LSP to place the product on hold. Informs the Primary Logistic Location and PGS Site/ESQA of quantity of product still within Pfizer control and follows the instructions regarding product disposition.

7.Oversight of local Relabeling and Repackaging Operations

Ensures relabeling/repackaging contractor has been internally assessed and approved. Obtains regulatory approval of the relabeling/repackaging activity. Coordinates all activities related to Pfizer products at the relabeling/repackaging contractor. Informs the releasing site of the relabeling/repackaging activity. Reviews documentation related to the relabeling/repackaging operation. When appropriate, releases the relabeling/repackaging product.

8.Development and Maintenance of Consistent Quality Culture

Collects data and metrics on the PCO's quality performance and communicates this to the Management of SCQ, PCO and RP. This involves a regular Management Quality Review process. Provides ongoing education on Quality to relevant PCO functional groups, to increase awareness and understanding of requirements and enhance the Quality Culture.

9.Suppliers' and Customers' Qualification

Ensures that suppliers and customers are qualified in accordance with GMP/GDP-requirements. Provides local support, upon request, to the RP, for the customers' qualification.

10.Pharmacovigilance and the compliance to rules and ethics codes

Completes in due time the "Your Reporting Responsibilities: Monitoring the Safety, Performance, and Quality of Pfizer Products" (YRR) training program and the annual re-training. Reports information regarding drugs' safety to the local Drug Safety Unit, in compliance with the YRR training materials. Has knowledge of and apply all the Compliance and Business Ethics rules. Reports any violation of the Compliance and Business Ethics rules.

11.Personal development through

Active participation in Pfizer trainings, assignments, projects. Active involvement in Pfizer internal and external meetings from commercial perspective. Identifies personal areas of improvement. Maintains a good work-life balance.

REQUIRED SKILL SET

Technical

  • Has an appropriate education in science or quality topics.

  • Has appropriate technical and quality experience to management expectations.

  • Makes sound and effective quality decisions under pressure.

  • Computer literate

  • Fluent Japanese and English communication skills - verbal and written

Managerial

  • Strong negotiation and effective communication skills.

  • Self-motivated individual who is comfortable with working independently

  • Awareness of cross-cultural differences

  • Able to lead and work effectively in cross-functional teams

Experience

  • Several years of relevant experience in the pharmaceutical industry

Knowledge

  • Familiar with the Japanese regulations and eligible to the role as Quality Responsible Person in accordance with the Japanese Pharmaceutical Low (Pharmaceutical and Medical Device Act)

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

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