6 days old

[UPJ] Pharmacist in Distribution Center (Sapporo

Pfizer
Freeland, PA 18224
  • Jobs Rated
    33rd
**MAIN RESPONSIBILITIES/DUTIES**

**ROLE PURPOSE**



+ The key role of the Pharmacist in the DC/LSP (hereinafter referred as Site) is to establish and maintain an appropriate and sustainable Quality Management System within the site in order to ensure compliance with Pfizer and Regulatory Authority expectations in Japan.

+ Pharmacist in site is the Quality Responsible Person related to distribution activities, focusing on the management of authorized activities and the accuracy and quality of records.

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

+ Pharmacist in site monitors the product quality and compliance activities within the DC/LSP, to ensure current regulatory expectations are met, and facilitate internal and regulatory GMP/GQP/GDP inspections.

+ Pharmacist in site is responsible for giving Quality support to any project in case of need.

+ Pharmacist in site will be able to get supports from his/her Manager to achieve the purpose above.



**KEY ACCOUNTABILITIES**



**1.** **Good Quality/Distribution Practice (GQP/GDP)**



+ Ensures appropriate implementation of Pfizer and GQP/GDP-related activities at the Site

+ Ensures appropriate implementation of Pfizer related activities at the Site

+ Is available and contactable during the whole operation time of the Site

+ Is present at the arrival of any incoming medicinal product shipments

+ Performs or supervises local quality assessment including organoleptic inspection of incoming products

+ Performs or supervises transfer to saleable stock of incoming products prior to distribution and/or sale

+ Verifies with a release statement that the medicinal product batch is handled and distributed according to the current local legal requirements, Priorities work according to most critical need on the markets

+ Investigates returned goods requests, approve or reject the return of the products

+ Decides on the final disposition of returned, rejected, recalled or falsified products

+ Performs or supervises quarantining of non-conforming products still within Pfizer control in order to prevent further distribution (short to expire and damaged products included)

+ Supervises the activities related to the separation of damaged products

+ Ensures Pfizer products under their responsibility are stored and transported in accordance with requirements

+ Ensuring that up-to-date records of performed wholesale activities are kept and retained for required retention period after the handling or distribution of a medicinal product batch

+ Tracks and resolves product quality compliance issues (deviation, commitment, product complaint, change control, retrieving missing information)

+ Reports any suspected deficiency in the quality of a medicinal product, and information on any suspected falsified medicinal product to the competent government body for pharmaceuticals and to the competent Pfizer stakeholders

+ Establishes and maintains an appropriate and sustainable Quality Management System

+ Ensures availability of Quality Agreements with internal Pfizer entities

+ Ensure availability of Quality Agreements with Site related external, contracted suppliers

+ Writes, reviews and/or approves key GQP/GDP related procedures regularly

+ Ensures that all elements of the Pfizer Training Quality System are implemented, oversights and maintenances the training programme of the Site

+ Ensures appropriate training and refresh training on GQP/GDP to colleagues with GQP/GDP-related activities at the Site

+ Monitors training program and leads Pfizer related training to the LSP warehouse personnel, when necessary

+ Ensures internal quality audits are performed and ensures follow-up on CAPA plans

+ Ensures external quality audits of service providers under Pfizer Japan responsibility when needed and ensures follow-up on CAPA plan

+ Facilitates internal and regulatory GQP/GDP/BoH inspections of the Site

+ Supports preparation and coordination of product quality and compliance (GQP/GDP/BoH) related inspections by regulatory authorities or Pfizer internal audits of the Site and Pfizer Japan

+ Supports coordination of inspections of Pfizer at the Site and follow-up of CAPA plan

+ Notifies the Management of significant deviations and complaints and any issue impacting marketed product

+ Ensures appropriate quality support is given to activities performed at LSP

+ Monitors appropriate handling of quality complaints and follow-up on root cause analysis and CAPA plan at the Site and LSP under their oversight

+ Tracks and develops/up to date Quality Agreements with GQP/GDP contractors

+ Facilitates the MSQA audit process at the site

+ Periodically assesses the overall quality risk associated to the contractor

+ Participates in qualification of suppliers and customers and/or consignees

+ Follows up distribution licenses of the customers

+ Performs and manages the authorized activities in compliance with GQP/GDP, Japanese regulatory and applicable Pfizer requirements

+ Keeps up-to-date records of performed wholesale activities, retains and archives records according to the requirements

+ Oversees quality operations at contractors and LSP

+ Participates in preparation and execution in self-inspection program

+ Notifies Immediate Manager in case of significant issues

+ Managements of Quarantine Alert Notices (QAN) of Pfizer products

+ Coordinates and promptly performs any recall operations for Pfizer medicinal products

+ Collects and provides the requested key quality performance indicators to Supply Chain Quality Lead, Upjohn Japan regularly

+ Supports the evaluation of the impact of all significant deviations affecting safety, identity, strength, purity and quality and agrees on CAPA

+ Ensures that relevant customer complaints are dealt with effectively

+ Keeps appropriate records of any delegated duties

+ Regularly informs the Immediate Manager of the performed GQP/GDP and supply chain related tasks



**2.** **Inspections and internal audits**



+ Leads preparation and coordination of product quality and compliance (GQP/GDP/MAH) related inspections by regulatory authorities or Pfizer internal audits of the Site

+ Establish and maintain excellent contact with Health authorities

+ Be the key contact person between Pfizer and the Japanese Authority

+ Ensure coordination of inspections of Pfizer at the Site and follow-up of CAPA plan

+ Ensure regular update of the wholesaler distribution authorizations and the narcotic and drug licence of the site

+ Prepares psychotropic substance reports related to the stock movements at the wholesale distribution site under their responsibility



**3.** **Local contractor quality oversight**



+ Ensures Quality Agreements are maintained and up to date with GQP/GDP contractors involved in repackaging, warehousing, transporting, material printing and transporting activities at LSPs

+ Oversees quality operations at contractors

+ Evaluates the impact of all significant deviations affecting safety, identity, strength, purity and quality and agrees on CAPA. If necessary, initiates the Notification to management process

+ Based on risk assessment, regularly visits the contractor

+ Reviews quality performance and agrees action plans to ensure continuous improvement

+ Periodically assesses the overall quality risk associated to the contractor

+ Facilitates the MSQA audit process at the contractor and LSP

+ Agrees with contractors on CAPA plans

+ Ensures all CAPA plans are documented and tracked

+ Notifies the Manager of significant concerns or repeated deviations occurred with contractors



**4.** **Oversight of local relabelling and repackaging operations**



+ Ensures that the relabelling/repackaging contractors have been assessed and approved

+ Oversees the repackaging activates managed via the Site

+ Approves the repackaging request

+ Reviews the documentation related to the repackaging/relabelling and performs the local transfer to saleable stock of the repacked/relabelled Pfizer product



**5.** **People**



+ Support people management in the team reporting to the Supply Chin Quality, Upjohn Japan

+ Participate on regular meetings with team and regular 1/1 meetings if needed



**6 .** **Main contact of**



+ Product Quality, Supply Chain, Regulatory Affairs, Drug Safety and Medical personnel of Pfizer Japan

+ Quality Assurance Pfizer Global Supply and Contract Operations

+ Warehouse manager and personnel assigned by the LSP for warehousing

+ Contact personnel of GQP/GDP-related outsourced activities

+ Quality Assurance personnel of Customers/Consignees

+ Regulatory Authorities



**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 Pharmacist in DC/LSP in accordance with the Japanese Pharmaceutical Low (Pharmaceutical and Medical Device Act)



/ Please submit application form in both Japanese and English.



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

Categories

Jobs Rated Reports for Pharmacist

Posted: 2020-10-13 Expires: 2020-11-12

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[UPJ] Pharmacist in Distribution Center (Sapporo

Pfizer
Freeland, PA 18224

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Pharmacist
33rd2018 - Pharmacist
Overall Rating: 33/220
Median Salary: $124,170

Work Environment
Good
59/220
Stress
Very Low
43/220
Growth
Poor
168/220
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