Regional Logistic Quality Manager, Asia Pacific

1 week ago

Ho Chi Minh City, Ho Chi Minh, Vietnam AstraZeneca Full time

Regional Logistic Quality Manager, Asia Pacific
At AstraZeneca, our work in Quality is important and valued.

We have an unrivalled forward-looking mindset, continuously innovating to find new and better ways to ensure we are improving outcomes for patients.

We take Quality seriously, drawing learnings from others to develop and understand what it takes to drive our modern mindset forward.

Here you'll feel empowered to step up, follow the science and evidence to make decisions that put patients first. We are a team of ambitious people, who want to go far and we're all here to achieve.


Join us as a Regional Logistic Quality Manager, this is an opportunity to champion a mindset of excellence in an environment where good can always be better.


About AstraZeneca and AstraZeneca Vietnam

AstraZeneca

Role background


The incumbent works closely with the AsiaPac Distribution Team and other Global Supplier Chain Quality Teams to support the performance of required QA activities within Asia Distribution and AstraZeneca Distribution Facility, and act as the QA leader for the management of assigned External Suppliers and AstraZeneca owned distribution facility within the team ensuring all GDP aspects are met.


Typical Accountabilities:

  • They are responsible for QA activities that support execution of Quality Management of Suppliers with regard to Distribution.
This includes the Quality System management and the performance of the following activities:

QA audits, change control, product quality complaint and deviation investigations, quality issue management and escalation, product disposition, QA Agreements (establishment and maintenance) between AZ and External Suppliers and between ASIAPAC Distribution, Marketing Companies and AZ Operations Sites.

This position requires strong cross-functional ways of working with non-QA members in the team.

  • This role also takes the responsibility to ensure the compliant quality management system set up and operated in AstraZeneca Distribution Facility, including and not limited to quality audits, change control, product quality complaint and deviation investigation, Training, Facility management, Calibration and Validation, Supplier Management, Package Conversion.
  • Ensure the quality business as usual (BAU) activities supporting the AstraZeneca Distribution Facility is well arranged and implemented, and accurately quality oversight was also provided. include but not limited to quality control check for inbound and outbound shipment, document management, training, temperature mapping, pack conversion and etc.
  • In addition, the preparation and submission of periodic Supplier Quality Assessments and performance the incumbent will also act. as the QA leader on new supplier introductions, projects, process optimization within ASIAPAC Distribution. Regulatory Agency interactions include assisting in the preparation for and management of Regulatory Agency inspections at External Suppliers and AZ Sites (when external suppliers are within the inspection's scope).
  • At the highest level, this position provides support to Distribution team members, working closely with the Distribution Managers (DM) and supporting QA and crossfunctional team members during issue resolution.
  • In relation to GDP or other relevant quality standard, ensure compliant distribution for new and existing AstraZeneca Pharmaceutical Products through internal and external assets and partners. The QA management includes;
  • Assessment, review and improvement of Quality Systems at Distributors and AstraZeneca Distribution Facility.
  • Quality Assurance Audit Program management including but not limited to the following:
  • Ability to be a "guest" Lead Auditor for GQA, or as audit team member support, QA/Compliance/GDP audit planning, execution.
  • Assess against regulatory agency & AZ quality/compliance standards, at Suppliers and AstraZeneca Distribution Facility, and ensure the delivery of the corrective actions/improvement opportunities as part of audit followup.
  • Ensure audit plan is agreed with GQA for suppliers and AstraZeneca Distribution Facility, in collaboration with Lead Auditor.
  • Perform Quality & Compliance assessments of potential suppliers to AZ and provide QA approval of the Supplier, based on their Quality and Compliance capabilities.
  • Provide expert QA input to, Asset Strategy and/or Value Delivery projects. This includes identifying and assessing Suppliers
  • Liaise with key customers in Operations to ensure successful delivery of projects
  • Make decisions and advise the function regarding quality issues
  • Responsible for Quality Assurance Supplier Management including but not limited to:
  • Quality Assurance Agreements;
- trending and reporting of data;
- assessing, reviewing and improving quality systems at Suppliers
- attendance at Quality Review Meetings

  • Interfaces with applicable site support groups on projects (capital and noncapital) that impact distribution,

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