Validation Facility Manager - Drug Product Manufacture
AstraZeneca / Apotekarjobb / Göteborg
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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 Technology and 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 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 then join a team that make an important contribution in delivering science for development and manufacture of new medicines.
The role
This is a technically advanced role, with no direct reports. The role holder has strong technical competence, credibility and ability to give assured direction and provide expertise regarding re-validation, documentation, change management, and validation activities mainly connected to facility (HVAC, Media systems, Clean in Place etc.) and manufacturing equipment - all with GMP validated status.The role has also solid focus on project management and validation expertise during major facility refurbishment and installation of new equipment/ technology.
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.
You are a vital part of the network driving our GMP asset utilization. Validation standard as well as connected documentation is key for our business. The role holder also participates in the preparation and provides documents and explanation concerning the processes for regulatory inspections at the Gothenburg site.
Requirements
* MSc in engineering or equivalent experience in validation.
* We are looking for a professional employee with high technical knowledge and project leadership skills who has the ability to operate independently in 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 appreciation of principles, applications and management of Engineering, Automation and current Quality Management standards. Excellent documentation skills both in English and Swedish. Interest in manufacturing equipment and automated systems are a benefit.
More information
For more information about the position please contact: Oskar Hedberg or Jonas Ödman at +46 31 776 10 00.
If you are interested, apply now!
Welcome with your application(CV and Personal letter) no later than June 15, 2018.
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.
Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2018-06-01ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2018-06-15
Ange följande referens när du ansöker: R-029088
Klicka på denna länk för att göra din ansökanKontaktAstraZeneca
daniela.borquez@astrazeneca.comFöretagAstraZeneca
AdressAstraZeneca
43183
43183 1480
KontorsadressPepparedsleden 1
Jobbnummer 4181306
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