QA Manager, Audit - R&D QA Gothenburg, Barcelona, Mississauga
AstraZeneca AB / Biomedicinjobb / Göteborg
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hela Sverige Do you have a keen curiosity about quality and would like to apply your skills and passion by joining a team of passionate, hard-working quality professionals? Would you like to contribute to the delivery of a high impact GCP-GVP audit program at AstraZeneca? Then this position is the right one for you!
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 up-to-date 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.
With that in mind the role is best suited to candidates with a drive to learn about quality. You will be capable at using technology, be self-managing and learning on the job. Accountabilities:
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 follow-up 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 logistical 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.
We encourage your application, no later than 13th July 2023.
Where can I find out more
Our Social Media, Follow AstraZeneca on LinkedIn:
https://www.linkedin.com/company/1603/Our Gothenburg site:
https://www.astrazeneca.com/our-science/gothenburg.htmlLife in Gothenburg:
https://www.movetogothenburg.com/ Ersättning Not Specified
Så ansöker du Sista dag att ansöka är 2023-06-13
Klicka på denna länk för att göra din ansökan Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "R-167767".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Astrazeneca AB (org.nr 556011-7482)
Arbetsplats AstraZeneca
Kontakt AstraZeneca
fredrik.larsson1@astrazeneca.com Jobbnummer 7835882
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