Validation Lead - Drug Product Manufacture
Poolia Göteborg AB / Organisationsutvecklarjobb / Göteborg
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hela Sverige We are now looking for a talented Validation Lead within Drug Product Manufacture at AstraZeneca Gothenburg. The 12-months consulting assignment will start 01-12-2018. Warmly welcome to Poolia Life Science and AstraZeneca. If you are interested, apply toda
The Arena
Pharmaceutical Technology and Development is accountable for delivering the design along with 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 Gothenburg manufactures prototype products (e.g. oral/inhaled solution/suspension, parenteral solutions, capsules, tablets and pellets) to AZ clinical studies around the globe. DPM is supporting a wide portfolio of projects across all AZ therapy areas. Establishing numerous new products annually, and with an overall supply of products to approximately 25 projects yearly, you will join a team that make an important contribution in delivering science for development and manufacture of new medicines.
We now have a temporary position in our team for one year, starting December 2018.
The role
The role is technically advanced without any direct reports and a vital part of the network driving our GMP asset utilization and to bring in new technology. High validation standards with excellent documentation is key for our business. The role holder therefore has strong expertise/technical competence, credibility and ability to lead and plan, perform and provide advice validation activities with focus on manufacturing equipment but also related to facility and systems (all with GMP validated status). You will also be accountable for DPMs overall validation strategy and lifecycle procedures.
The role holder collaborates closely with internal and external partners ensuring compliance within the framework of GMP and SHE. An interest to drive continuous improvement of capabilities to improve our capacity and agility is expected.
The role holder also supports the preparation and actively participates during regulatory inspections at the Gothenburg site, providing evidence of our validation procedures and activities using relevant documentation
Requirements
MSc in engineering or equivalent experience in validation.
We are looking for a professional employee with high technical knowledge, documentation, change management and project leadership skills who has the ability to operate independently with good collaboration in a culturally diverse, complex and changing environment. The applicant should have a good understanding of development within the industry and how they impact the function.
You will have knowledge of cGMP and an appreciation of the principles, applications and management of Engineering, Automation and current Quality Management standards. Excellent documentation skills both in English and Swedish. An interest in manufacturing equipment and automated systems is essential.
About AstraZeneca
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.
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2018-10-05ErsättningFast månads- vecko- eller timlön
Så ansöker duSista dag att ansöka är 2018-10-14
Ange följande referens när du ansöker: 51545
Klicka på denna länk för att göra din ansökanFöretagPoolia Göteborg AB
AdressPoolia Göteborg AB
Kungsgatan 42
41115 Göteborg
KontorsadressKungsgatan 42
Jobbnummer 4386963
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