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.
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.
- 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
What we offer you at ALTEN
Every employee is equally valuable in the success of ALTEN! We are driven by making people grow and develop, which is why we offer you the opportunity to work with what you are truly passionate about. At ALTEN, we have a broad range of assignments at most of the leading companies in Sweden in several different sectors, to make it possible for your wishes to come true. We offer both national and international opportunities and together with your coaching manager, you build your career path so you constantly are able to develop and achieve your goals and dreams!
As a consultant at ALTEN, you will get the genuine team feeling at your assignment but also a wonderful togetherness at ALTEN. Through our different internal networks, such as ALTEN Sports, Women@ALTEN and ALTEN Innovation you will get the opportunity to drive topics and activities that are close to your heart, together with your colleagues. All activities are of course optional. Work life balance is our top priority. We also have a collective agreement and other benefits like Pension, Insurances and Wellness grants.
We believe in growing together!
Ansök till Operations Regulatory CMC to Astra Zeneca
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