CMC Administrator

3PS (3rd party supply) CMC Administrator

Modis Life Science is looking for a 3PS (3rd party supply) CMC Administrator to AstraZeneca in Södertälje. The consultant assignment will start as soon as possible and proceed until the end of 2018.

Welcome with your application no later than February 14h!

Om 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.

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 (Södertälje), you will join a team of Regulatory system specialists within a global Operations Quality function based both in Gärtuna and Macclesfield, UK.

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.

This is a relatively new role and thus you will be expected to work alongside another 3PS CMC administrator participating in the development of any processes required to achieve the above.

Essential requirements:
· Educated to degree level in a science-related discipline
· Strong IT skills, experience of document management systems preferable
· Self motivated and capable of working under minimal supervision
· Excellent communication skills (written and oral)

Desired requirements:
· High level understanding of GMP and working in a regulated environment
· High level understanding of CMC Regulatory CMC knowledge

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status or any other characteristic protected by law.

What do we offer?
Modis Life Science is a specialized Business Line within Adecco group. We work exclusively with Staffing Services and Recruitment of personnel within the Life Science industry. Our expertise lies within all areas of Life Science such as R&D, Production, Quality Assurance, Clinical Research, Regulatory Affairs, Medical Affairs, Marketing & Sales and many more. Our customers are companies, of different sizes, within the Pharmaceutical-, Biotech- and Medtech- industries. As the largest recruiting and staffing company in the world our most valuable assets are our consultants. With us, you as a consultant will be appreciated for your difference-making competence within Life Science!

Modis Life Science can offer you the opportunity of interesting assignments and positions at attractive companies that perhaps never will be put out on the open market! For your security as a consultant, you are covered by our collective agreement and by insurance and corporate healthcare. We also want you to stay healthy and therefore offer you healthcare contributions and discounts on training cards. We arrange social activities continuously where you can share your experiences with our other consultants.

Are you interested?
Then you should apply as soon as possible. The position is soon to be filled and therefore work with recruitment is being done on a continual basis.
If you have questions regarding the position contact Anneli Bermbeck, anneli.bermbeck@modis.se