HBS Compliance Specialist

Qrios Minds AB / Biomedicinjobb / Göteborg
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Human Biological Samples (HBS) are fundamental to medical research in the discovery, development and implementation of new treatments and diagnostics. HBS are ethically sensitive materials and the collection, handling and access to HBS are subject to strict regulations, principles and ethical guidelines.

The AstraZeneca Biobank maintains a data repository with appropriate human subject protection and industry best practices. The Biobank stores HBS, banked or prospectively collected from geographically diverse populations.
We are now looking for you who would like to join our team on a 12-month assignment and play a pivotal role in this exciting period of development!

Responsibilities
The Compliance specialist (CS) role will co-ordinate projects and assist in delivery under the supervision of the Compliance associate Directors and project leads to ensure collation of all information related to HBS. The post holder will be required to work with the biobank to reconcile the HBS inventory against compliance information to allow decision making on inventory.

In addition, you will:
• Collaborate with the internal teams in locating documentation and reviewing consent for requests related to HBS in AZ.
• Assist in knowledge curation to allow decision making on inventory which maybe in AZ, or third parties. Duties may include handling of HBS during the reconciliation and curation process.
• Work with the HBS C&G team and Biobank leads to ensure that learning from HBS related issues are identified and analysed to enable continuous process improvement.
• Electronically manage HBS retrievals including receipt, tracking, review and approval of requests from internal requestors. Confirm requests against the informed consent, raise requests as the need arises.
• Assist with the resolution of issue and queries relating to HBS within the inventory. Maintain records for HBS stored until it meets final disposal and follow destruction process when initiated.

Your profile
• Project management experience and skills is preferable
• Experience with administrative tools
• Experience in pharmaceuticals, a healthcare related industry or academia/hospital environment related to HBS
• Excellent analytical, written and oral communications skills together with excellent English written and verbal communication skills
• Knowledge and understanding of compliance function, health care regulations, laws, and standards (HBS)

• Excellent analytical, written and oral communications skills.
• Proven team working skills
• Ability to work independently
• High ethical standards, trustworthy, operating with absolute discretion

About the organisation
This is a consultant assignment at AstraZeneca in Gothenburg for 12 months. During this time you will be hired by us at QRIOS.
QRIOS can offer several opportunities for skilled people with a background in biochemistry, chemical engineering or science. We work with Sweden's leading pharmaceutical and life science companies. So whether you're interested in research, regulatory affairs, quality assurance, environmental and quality control, sales and marketing, or just want a career change, we have the job for you.

Working as a consultant suits whoever wants to get a lot of experience in a short period of time. We offer you the chance to work with well-known brands at renowned companies where you can develop your skills. If you're looking for a world of exciting assignments and new contacts, you'll like being a consultant.

About Astra Zeneca:
AstraZeneca is a major international healthcare company engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. But we are more than one of the world's leading pharmaceutical companies - at AstraZeneca, we are proud to have a unique culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.

Ersättning
Fast lön

Så ansöker du
Sista dag att ansöka är 2024-03-12

Arbetsgivarens referens
Arbetsgivarens referens för detta jobb är "1015".

Omfattning
Detta är ett heltidsjobb.

Arbetsgivare
Qrios Minds AB (org.nr 556599-5999), http://www.qrios.se/

Arbetsplats
Qrios Life Science & Engineering AB

Kontakt
Alma Foric
alma.foric@qrios.se
073-850 49 73

Jobbnummer
8468335

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