QA Manager, Audit

hace 1 semana

Barcelona, Barcelona, España AstraZeneca A tiempo completo
At
AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality.

If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.


R&D Quality Assurance are a group of over 70 Quality Assurance professionals located at R&D sites worldwide. Our purpose is to promote and optimise quality, providing assurance in AstraZeneca's delivery of life-changing & innovative medicines to patients.

R&D QA provides assurance and proactively partners with stakeholders to share data-driven insights, advice and expertise.

R&D QA commits to provide our stakeholders with an experience that:

  • Is driven by patient protection and data integrity.
  • Represents Regulators' current and future views.
  • Optimises quality thinking and promotes a 'right from me' approach.
  • Focuses on issues that matter, minimises risks and drives thoughtful outcomes.
  • Provides simple, structured and efficient systems, with uptodate quality information.

What you'll do


As an
Manager, Audit your
core duty will be in the support and delivery of audit related activities from the R&D GCP-GVP audit program.

You will be working & developing alongside a team of dedicated auditors globally, and be able to contribute to the success of the Audit team in R&DQA.

More specifically you will support quality and compliance risk management for functional area using risk framework standards to define risk and develop mitigation recommendation.


The Audit QA team is responsible for the delivery of > 250 GCP-GVP risk based audit audits annually across the AZ Enterprise.

You will be working as either part of a small audit team under a lead auditor or learning to lead simple audits alone depending on your skills and knowledge.

You will be able to interact with collaborators across R&D and bring your enthusiasms for quality to those interactions.

Audit

  • Works with contract personnel or consultants to prepare, conduct and report outsourced audits.
  • Supports Supplier qualification activities (Operational Due diligence ODD) as assigned.
  • Identify and summarize gaps during ODD.

Capa

  • Assesses need for, and assists in development of CAPA plans, approves and monitors plans to completion for assigned audits.
  • Assists with the continuing followup of agreed audit CAPA actions from across QA to assist in the monitoring of QA Key Performance Indicators.

Inspection

  • May support Quality Assurance colleagues to prepare for regulatory inspections and assist with planning and logístical arrangements.

Essential qualifications

  • Degree level education or equivalent experience in the pharmaceutical area & experience in pharmaceuticals or a related industry.
  • Excellent analytical skills.
  • Expert communicator in written and spoken English with the ability to communicate effectively with QA colleagues and business partners, and have the ability to develop professional networks with collaborators.
  • High ethical standards, trustworthy, operating with absolute discretion.
  • Collaborative, influencing and interpersonal skills curious to understand business environment.
  • Maintains knowledge of relevant industry information affecting quality and compliance arena.
  • Be able to travel when required.

Desirable

  • Audit Experience.
  • Supplier qualification.
  • Experience of regulatory health authority GxP Inspections.

Why AstraZeneca


At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big.

Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential.

Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be.

This means we're opening new ways to work, pioneering innovative methods and bringing unexpected teams together. Interested - come and join our journey

So, what's next
Are you already imagining yourself joining our team - good, because we can't wait to hear from you. If you have any questions please get in touch with Tracy Gilbert to discuss further.

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