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CMC Associate to AstraZeneca

Företag Modis Sweden AB
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2019-07-03

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CMC Associate to AstraZeneca

Modis Life Science is now looking for a CMC Associate to AstraZeneca in Södertälje. This is a 12 month  consultancy assignment and as a consultant you will be hired by Modis. The assignment will start August 1st. Send your application in English no later than June 15th.

About the assignment

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. This 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.

You will liaise with internal Regulatory specialists and external partners and be responsible for the upload of CMC documents into a document management system. Compliance with established good documentation practices such as 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 documents, 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 partners and for communication to relevant manufacturing sites.

You will be part of the 3PS Quality network and act as a key contact person for ensuring dossier visibility.

You will be expected to work alongside another 3PS CMC associate participating in the improvement of processes required to achieve the above.

Essential requirements:

  • 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 CMC knowledge

For questions, please contact Cecilia Larzon (cecilia.larzon@modis.se)

Dela detta jobb

CMC Associate to AstraZeneca

Modis Sweden AB