Four Scientists or Senior Scientists, Drug Produ
AstraZeneca Mölndal / Biologjobb / Mölndal
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hela Sverige AstraZeneca (AZ) is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.
The arena
Pharmaceutical Development is accountable for delivering the design, innovative, efficient and robust processes for the manufacture of drug substance and product, the supply chain of products for safety and clinical trials and the generation of information and knowledge to ensure regulatory approval of new products.
Drug Product Manufacture (DPM) in Mölndal manufactures investigational products (oral solution/suspension, parenteral solutions, capsules, tablets and inhalers) to AZ clinical studies mainly in phase I/II around the globe and is a vital part of the Pharmaceutical Development Supply Chain organisation. At DPM in the GMP (Good Manufacturing Practice) arena you will make an important contribution in delivering clinical results and new medicines.
The role
This role significantly contributes to the manufacturing of drug product in development phase for clinical studies. All below activities will have a significant impact on the speed, quality and cost of the AZ development portfolio.
Responsible for the timely and cost effective manufacture of drug product in line with the plans agreed within DPM, including practical hands-on work in our pilot plant GMP facilities.
Strong technical competence, credibility and ability to give assured technical direction.
Set up Master Manufacturing Records and Batch Records and perform transactions in Warehouse Management System through the Supply Chain IT-systems.
Assess record and report manufacturing and validation data accurately according to GMP.
Ensure SHE (Safety Health and Environment) and GMP standards are upheld and ensure AZ Policies and Standards are understood and followed.
Establish and recommend ways to improve flexibility and productivity, including new ways of working, resulting in shorter lead times.
Monitor and track relevant Key Performance Indicators (KPIs).
May act as Authorized Person for product manufacture.
May write GMP & SHE procedures within own area.
May supervise new co-workers and contribute to their training and development by acting as coach/mentor.
Parenteral manufacture and hygiene control
In addition to the above description one role holder will also have special competence in the field of microbiology and hygiene control of Water/Water for Injection and facilities. Experience of parenteral manufacture is preferred for this role.
DP Manufacture Lead
In additional to the above description one role holder will also act as DP Manufacture Lead, working within an agreed development project portfolio, the role holder is responsible for the manufacture of investigational products to agreed milestones and acts as point of contact for ....
For application and to read FULL JOBDESCRIPTION please visit
www.astrazeneca.sePubliceringsdatum2013-01-22Arbetstider och omfattningTillsvidare
Heltid
ErsättningFast lön
Så ansöker duSista dag att ansöka är 2013-02-15
Ange följande referens när du ansöker: MOL000000XU
Ansökan kan tyvärr inte göras via e-post.
FöretagAstraZeneca Mölndal
AdressAstraZeneca Mölndal
43183 MÖLNDAL
KontorsadressPEPPAREDSLEDEN 1
MÖLNDAL
Övriga kontaktuppgifterTelefonnummer: 031-7761000
Jobbnummer 1445230
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