Operations Regulatory CMC Analyst

Operations Regulatory CMC Analyst
On behalf of AstraZeneca we at Dfind Science & Engineering are now looking for candidates for a consultant assignment within Regulatory Affairs planned to last until december 2017. During this assignment you will have the position as Operations Regulatory CMC Analyst placed at AstraZeneca in Södertälje.

About AstraZeneca:



At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality.

At AstraZeneca, innovation is about more than just research. We aim to stimulate continued creativity throughout our organisation by maintaining a culture in which our people feel valued, energised and rewarded for their ideas and contribution to our success - ideas which can make a difference in all aspects of our business.



Job description:



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.



Typical accountabilities:



You will be responsible for the upload of manufacturing documentation provided by external partner companies into an existing document<t 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.



This is a new role and you will be expected to participate in the development of any 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 knowledge

Business: Dfind Science & Engineering

City: Södertälje

Job type: Full time

Deadline for applications: 2017-09-05

More information: Julia Gonzales, julia.gonzales@dfind.se, 0733434654 or Sofie Önnestam, sofie.onnestam@dfind.se, 073 343 99 61

Please send your application in English.

We encourage you to send your application as soon as possible, since interviews and candidate selection are done continuously! We put great emphasis on personal suitability for this role.

Organization/Business description:

Dfind Science & Engineering is part of Randstad, one of the Nordic region's largest specialists within staffing, recruitment and outplacement.

Dfind Science& Engineering is specialized in recruitment and consulting providing competences within Life Science, Science and Engineering and is a company where people make all the difference. At Dfind Science & Engineering specialists are recruiting specialists!

All our recruitment consultants , consultants and sourcing managers have a technical or scientific background, combined with extensive networks within relevant communities and expertise within recruitment and HR. We understand our customers specific requirements and know how to find the best candidates. Through our passionate commitment and high degree of attentiveness we help people and businesses to grow and be competitive in a changing world.