Lead Quality Advisor
AstraZeneca / Apotekarjobb / Göteborg
2018-05-30
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➡️ Klicka här för den senare publicerade platsannonsen "Lead Quality Advisor" (publicerad 2018-08-28) ⬅️
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hela Sverige Visa alla jobb hos AstraZeneca i Göteborg,
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hela Sverige Are you interested in a challenging opportunity within the Development Quality function in one of the world's leading pharmaceutical companies?
The Development Quality function is responsible for quality oversight of the pharmaceutical development activities in AstraZeneca. We are now looking for a Lead Quality Advisor with experience as a Qualified Person to our Gothenburg team. AstraZeneca's pharmaceutical development organizations deal with all facets of the process of turning a molecule into a medicine which can be safely and effectively used by patients. The Lead Quality Advisor role has a broad range of responsibilities to ensure all internal and external requirements are fulfilled for the AstraZeneca projects in the development phase, including ensuring safe and compliant medicines for the AstraZeneca clinical programmes. You will also have the possibility to contribute with expert advice to the pharmaceutical development functions and to the delivery of our pipeline of exciting new medicines.
The role
* Perform final QP certification of Investigational Medicinal Products.
* Provide expert support and guidance to pharmaceutical project teams and supply chain teams for complex projects including technology transfer to commercial manufacturing sites and contractors.
* Lead the delivery of QA activities for an assigned portfolio of projects. Accountable for aligning all QA activities across a project and empowered to resolve any project quality issues.
* Lead pre-approval inspections (PAI) preparations to assure the integrity of data and readiness for inspection
* Ensure appropriate Development Quality input to major business improvement projects.
* Develop and maintain in-depth knowledge of the quality regulations and guidelines applicable to the area of responsibility.
* Mentor, support and inspire junior colleagues for enhanced individual and team performance.
* Close collaboration with AstraZeneca QA colleagues globally.
Minimum requirements - Education and Experience
* Fulfils the requirements from MPA (Läkemedelsverket) to be a Qualified Person
* Experience as Qualified Person for investigational products.
* Appropriate scientific degree with extensive experience (5-10 years) of working within a pharmaceutical GMP environment.
* A broad and comprehensive understanding of GMP Quality Systems aligned to ICH Q10.
* A comprehensive understanding of the pharmaceutical/drug development process.
* Fluent in written and spoken English.
*
Preferred requirements
* Excellent team working and networking skills
* Demonstrates independent judgement, integrity and personal credibility
* Capable of making decisions based on risk considerations and business acumen in complex situations
* A good communicator with experience of interacting effectively across interfaces
* Builds excellent relationships with stakeholders, both internal and external
* Experience from working with formulation, analytical or device development
More information
For more information about the position please contact: Bodil Egeland, Director Development Quality, Gothenburg at +46 31 706 4701
If you are interested, apply now!
Welcome with your application no later than 13 June 2018.
Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2018-05-30ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2018-06-13
Ange följande referens när du ansöker: R-028939
Klicka på denna länk för att göra din ansökanKontaktAstraZeneca
daniela.borquez@astrazeneca.comFöretagAstraZeneca
AdressAstraZeneca
43183
43183 1480
KontorsadressPepparedsleden 1
Jobbnummer 4175876
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