3PS (3rd party supply) CMC Administrator
Alten Sverige AB / Sjukhusteknikerjobb / Stockholm
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hela Sverige ALTEN Pharma in Stockholm is looking for a 3PS (3rd party supply) CMC Associates for a consultancy assignments at AstraZeneca in Gärtuna (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.
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<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 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.
ABOUT ALTEN
For over 20 years, ALTEN has developed its business by keeping to the core values ??that have built up the company's success. Every year, hundreds of ALTEN consultants have been given the opportunity to embark on challenging technical projects for our customers. ALTEN has a tradition of developing products in many areas, and history in Sweden is based primarily on skills in mechanics, software and electronics. Thanks to a successful concept in which we utilize the expertise of experienced consultants and develop young abilities towards a successful career, we have gained ground in many industries. Our Pharma initiative is based on the same successful concept with the same strong structure, but in a new exciting industry and a new field of expertise that includes knowledge in chemistry, biotechnology and biomedicine.
As an employee at ALTEN, we offer you a competitive salary based on your performance and work experience. You also have the opportunity to influence your assignments, different benefits and your overall working environment as well as choose your career path. We offer a wide range of internal trainings and an opportunity to plan for an international career. It is our conviction that genuine commitment is created through choice and the ability to influence your own personal development - our business model provides that opportunity. This freedom of choice enables us to offer our clients the most committed consultants, regardless of assignments. At ALTEN, we believe in growing together!
For questions about the position, please contact Karin Söderlind, Business Manager Pharma, at
karin.soderlind@alten.se.
Varaktighet, arbetstid
Heltid Tillsvidareanställning
Publiceringsdatum2018-01-31ErsättningEnligt överenskommelse
Så ansöker duSista dag att ansöka är 2018-02-16
Klicka på denna länk för att göra din ansökanKontaktHR-avdelningen, Alten
FöretagAlten Sverige AB
AdressAlten Sverige AB
Theres Svenssons gata 15
41755 Göteborg
KontorsadressTheres Svenssons gata 15, Göteborg
Jobbnummer 3936087
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