Arbetslivsinstitutet.se

3PS (3d party supplier) CMC Associate to AstraZeneca


1 platser Tillsvidare Heltid Enligt Överenskommelse Heltid tillsvidareanställning

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.
 
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

What we offer you
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, [email protected] 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!

NOTE! Due to vacations during the weeks 28-33 the selection process may take longer than usual and feedback might not be provided right away but we will handle it as soon as possible.

Kontaktpersoner på detta företaget

Pontus Kastrup

Peter Ankréus
+4621349931
Patrik Juhlin
+46214404220
Johan Hägg

Johan Hägg
+46709715805
Andreas Forsberg
+46134655889
Stavros Constantinou
+46134655803
David Kronholm
+46317251131
Ulrika Lin
+46317576133
Erik Rosenqvist
+46317221361
Erik Rosenqvist
+46317221361
Martin Ericson
+46317193666
Delise Nilson
+46317576201
Charlotta Utterström
+46317576200
Anders Rohdin
+46317622664
Joachim Johansson
+46317622760
Johan Grankvist
+46317251034
Sven Andersson

Josefine Sandahl

Jonas Theodorsson

Anders Aadland
+46317576145
Emma Leppäjoki

Anna Edin

Thomas Montgomery

Gustav Caesar
+46317622475
Fredrik Skager

Josefine Sandahl

Simon Gelmanovski

Erik Lindmark
+46465409651
Anna Edin
+46317576235
Mikael Sörensson
+46317576081
Thomas Montgomery
+46709714187
Richard Kahl
+46317251175
Elias Bernerskog
+46317622480
Sven Andersson
+46733534400
Andreas Andblad

Therése Engström

Anders Aadland

Louise Hagströmer
+468518 19 620
Josefine Sandahl
+46721515200
Anna Andersson

Jonas Theodorsson
+46856251419
Göran Sandström
+460841081640
Adriana Thelander

Lars Persson
+46317251114
Martin Öhman
+46841081633
Filip Rosander

Andreas Andblad
+46317251055
Emma Leppäjoki
+46317622712
Delise Nilson
+46317576201
Ulrika Lin
+46317576133
Josefine Sandahl
+46765535928
Sven Andersson

Peter Hygren
+46733534122
Henrik Svala

Richard Rydell
+ 47 91 655 660
Sandra Bolin

Andreas Johansson

Robert Eriksson
+46723532323
Joakim Norberg
+46317622343
Martin Segerström
+46317622416
Monica Hellroth
+46841081692
Pierre Östlund
+46709715840
Henrik Svala
+46317193605
Sandra Bolin
+46709715813
Therese Nilsson

Niklas Sjöstrand
+46723532405
Andreas Johansson
08-5625 1400
David Kronholm
+46317251131
Patrik Blomqvist
+46709714139
Joseph Shaya

Admir Dervisic

Therese Nilsson
+46-709 71 58 48
Sara Lundström
+46856251460
Nils Löfgren
+46730644359
Helene Schagerlind
+46709607620
Richard Rydell
+46 723532388
Helena Larbo
+46841081507
Matilda Frid
+46851838080
Joseph Shaya
+46731554084
Joakim Strandberg
+4722837070
Therese Nilsson
+46709715848
William Johansson
+46734418633
Stavros Constantinou
+46134655803
Sandra Bolin

Madeleine Holm
0725237219
Peter Ankréus
+4621349931
Jonas Theodorsson
+46856251419
Sara Henriksson
031-7251144
Madeleine Holm
0723532227
Robert Winter
+46723532323
Sofia Näverbrant
+46317221232
Björn Waern
+46841081668
Magnus Flink
0701693719
Ida Thomasdotter Eriksson

Simon Levén
+46317251194
Andreas Johansson

HR-avdelningen, Alten

HR-avdelningen, Alten


Ansök

> Sista ansökningsdatum: 18 July 2019

Alten Sverige AB

Besöksadress

Teknikringen 8
None

Postadress

A Odhners Gata 41
Västra Frölunda, 42130

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