Operations Regulatory CMC - Analyst
Poolia Life Science & Engineering AB / Kemistjobb / Södertälje
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On behalf of our client, AstraZeneca, we are now looking for a Operations Regulatory CMC - Analyst for a temporary consultant position. AstraZeneca is operating as a supplier for divested products where the manufacturing licence is now owned by an external partner. As part of this relationship there is a requirement to ensure that AstraZeneca manufacturing network has full visibility and access to the current regulatory approved Chemistry Manufacturing and Controls (CMC) dossier for each country where the product is marketed. It is critical in ensuring that products are manufactured in compliance with the licences held by the third party licence holder.
Whilst this role is based in Gärtuna, you will join a team of Regulatory system specialists within a global Operations Quality function based both in Gärtuna and Macclesfield, UK.
The assignment which is full-time will start ASAP with the duration of twelve months. Selections and interviews are held on an ongoing basis, so please submit your application as soon as possible. Cover letter and CV must be in English.
Arbetsuppgifter
You will be responsible for the upload of manufacturing documentation provided by external partner companies into an existing document management system. Compliance with established good documentation practices such as document version control, ensuring business approval and document format will be part of this work. Communication of any changes to this information, such as new market approved documentation, to the relevant manufacturing sites is also a critical success factor. Additionally, you will be required to ensure that AstraZeneca's change control system is maintained to reflect regulatory assessments supplied by the third party. You will responsible for the upload of documents provided by external partner and communicate to relevant manufacturing sites.
You will be part of the 3PS Quality network and act as a key contact person for administration of documents related regulatory changes received from the external partner. As this is a new role, you will be expected to participate in the development of any processes required to achieve the above.
Utbildning/erfarenhet
Skills & Experience:
• Educated to degree level
• Strong IT skills, experience of document management systems preferable
• Self motivated and capable of working under minimal supervision
• Excellent communication skills (written and oral)
• High level understanding of GMP and working in a regulated environment
• High level understanding of CMC Regulatory knowledge
Förmåner
We take good care of our consultants and we offer social activities, as well as help in planning your future career. Your consultant manager is well experienced from your field, and knows how to get the most out of your assignment.
As a Poolia employee, you are included in the requirements concerning agreements on terms of employment by Unionen. Moreover, you get a grant for working out at your choice of place. You are also covered by a health insurance.
Företagsbeskrivning
Poolia Life Science 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.
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.
Sluttext
Please apply by registering your CV here on our website. Click on the "Ansök" button to the right. It is our recommendation that you register as much information as possible and that you attach a complete CV-document. Please check that your correct e-mail address is registered.
Poolia is a registered staffing agency, meaning that we comply with the requirements set by Bemanningsföretagen - the Swedish Association of Staffing Agencies.
Language
en-GB
Varaktighet, arbetstid
Heltid Visstid, mer än 6 månader
Publiceringsdatum2017-07-05ErsättningFast lön
Så ansöker duSista dag att ansöka är 2017-07-30
Ange följande referens när du ansöker: 47260
Klicka på denna länk för att göra din ansökanKontaktCaisy Kader
caisy.kader@poolia.seFöretagPoolia Life Science & Engineering AB
AdressPoolia Life Science & Engineering AB
Box 207
10124 Stockholm
KontorsadressBox 207
Jobbnummer 3591335
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