Stability Quality Assurance Manager
Dfind Science & Engineering AB / Kemistjobb / Stockholm
Observera att sista ansökningsdag har passerat.
Visa alla kemistjobb i Stockholm,
Solna,
Lidingö,
Sundbyberg,
Danderyd eller i
hela Sverige Visa alla jobb hos Dfind Science & Engineering AB i Stockholm,
Solna,
Sundbyberg,
Danderyd,
Huddinge eller i
hela Sverige Stability Quality Assurance Manager
Stability Quality Assurance Manager (SQAM)
On behalf of AstraZeneca we are now looking for candidates for a consultant assignment as a Stability Quality Assurance Manager. You will be employed by Dfind and this will be your first assignment. As our consultant you get a secure employment with collective agreements (Almega), fixed monthly salary and benefits such as healthcare, occupational health insurance, insurance, ITP pension and health care allowance.
Dfind Science & Engineering is a consulting and recruitment company specialized in science and technology skills. We arrange various events and training courses for our consultants that enable exchange of experience, networking and insight into working in different roles and companies. With us, you get a consultant manager who is committed to your assignment and career development.
About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. 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.
The arena
Global Stability Management (GSM) is a Central Quality Operations group, responsible for the technical support of all established, small molecule products and major brands developed in AZ, including the responsibility for the management of the AZ global stability program and all the associated activities.
GSM is responsible for the Management of the commercial stability Program and Quality system which supports all AstraZeneca's small molecule Drug Substances and Drug Products. GSM has prime accountability for proactive and focused support on all aspects of stability management for all global Operations sites and CMOs. The group has a technical, scientific and regulatory skill set.
The role
The SQAM has responsibility for a Commercial product portfolio. The job holder is responsible for Stability Quality Assurance, in relation to all aspects of the global commercial stability management and will evaluate stability information to support license management for global commercial products.
Overall surveillance of data, global product stability profiles and issues arising from the global commercial stability program by evaluation and trending across all stability information:
• Technical assessment of impact of; supply chain changes, process and packaging changes, and translation of these into appropriate programs of stability studies.
• Assurance of the integrity of stability study reports intended for submission to regulatory agencies, including; selection of studies; scientific rational used in discussions/conclusions; compliance with the regulations of the health authorities that will receive the report.
• Initiate/coordinate/participate in investigations
• Stability QA support for Operations sites, e.g. stability contribution to APR/PQR, Temperature Excursions, Health Authority inspections, Stability technical support.
• Commercial stability input to NPI projects and take over the stability QA responsibilities after handover from R&D.
Profile
• Educated to BSc level, fluent in Swedish and English
• Thorough knowledge of cGMP requirements and their applicability to Operations and Quality.
• Strong communication skills and ability to build effective relationships with team and customers.
• Excellent team working skills
• A solution based approach
Preferred experience/requirements
• Experience in Operations and/or R&D
• Strong knowledge of and background in Quality systems eg stability management, QC or QA
• Able to demonstrate the drive and energy to establish the role and make a difference.
Business: Dfind Science & Engineering
City: Södertälje
Job type: Full time
Deadline for applications: 2018-06-08, We encourage you to send your application as soon as possible, since interviews and candidate selection are done continuously! We put great emphasis on personal suitability for this role.
More information: Sofie Önnestam,
sofie.onnestam@dfind.seOrganization/Business description:
Dfind Science & Engineering is part of Randstad, one of the Nordic region's largest specialists within staffing, recruitment and outplacement.
Dfind Science & Engineering is specialized in recruitment and consulting providing competences within Life Science, Science and Engineering and is a company where people make all the difference. At Dfind Science & Engineering specialists are recruiting specialists!
All our recruitment consultants, consultants and sourcing managers have a technical or scientific background, combined with extensive networks within relevant communities and expertise within recruitment and HR. We understand our customers specific requirements and know how to find the best candidates. Through our passionate commitment and high degree of attentiveness we help people and businesses to grow and be competitive in a changing world.
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2018-05-28ErsättningFast lön
Så ansöker duSista dag att ansöka är 2018-06-08
Ange följande referens när du ansöker: 201151048
Klicka på denna länk för att göra din ansökanKontaktSofie Önnestam
sofie.onnestam@dfind.seFöretagDfind Science & Engineering AB
AdressDfind Science & Engineering AB
Regeringsgatan 65
10724 STOCKHOLM
KontorsadressRegeringsgatan 65, 10724 STOCKHOLM
Jobbnummer 4169405
Observera att sista ansökningsdag har passerat.