Regulatory 3PS CMC associate

Regulatory Affairs Associate
job description.

Randstad Life Sciences is now looking for candidates for a consultant assignment as 3PS CMC Associate at AstraZeneca in Södertälje. The assignment is planned to start in august and is planned to last until 2020-07-30.

As a consultant at Randstad, you are employed by us and work for one of our clients. You have the same benefits with Randstad as with any other employer with a collective agreement and benefits such as a wellness grant, occupational health care, insurances and discounts on gym memberships. In addition, you are offered a range of career opportunities. You get the chance to experience different company cultures and to gain experience from different industries, which helps you in developing your skills and building a well-rounded CV. The position can include many contacts and hence, it is important that you have a good ability to cooperate with others and good skills in communication. As a person, we see that you are driven and used to work independently. If you are looking for an employer that offers different assignments and new contacts, then you will enjoy being part of Randstad.



description.

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



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.



application.

Last day for applying is 2019-09-04, selection and interviews will be ongoing. The position may be filled before the last day of application, therefore, apply as soon as possible.

For more information: Katrine Wirsand, katrine.wirsand@randstad.se, please note that we do not accept or process applications through email due to GDPR.



about randstad.

With more than 600 000 employees in 38 countries, Randstad is the global leader in the HR services industry and offers staffing, consulting and recruitment solutions in all areas of expertise. We also offer interim management, executive search and outplacement services. We have a large network of clients and candidates, which means that we convey hundreds of jobs within different industries all over Sweden. Our ambition is to be the best employer in the market.

By combining our passion for people with the power of today’s technology, we help people and organizations to reach their true potential. We call it Human Forward.