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Stability Program Manager (SPM). Stockholms län. Suecia

Trabajo en Suecia (Stockholms län) de Químicos

Clasificación del trabajo: Profesionales científicos e intelectuales : Profesionales de las ciencias y de la ingeniería : Físicos, químicos y afines : Químicos.

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Descripción de la oferta de trabajo:

Stability Programme manager

Stability Program Manager (SPM)

On behalf of AstraZeneca we are now looking for candidates for a consultant assignment as a Stability Program 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.

Om 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 SPM is responsible for ensuring by generation, provision and maintenance of the Global Commercial Stability Program.

• Generation and maintenance of the Stability Master Plans and the supporting stability test protocol information 

• Ensure the global stability program fulfils all regulatory requirements, and is optimized and effective.

• Communication of the Stability Master Plans to the Stability QC Centres.

• Translation of stability sections in CMC documentation and Commitments into the Stability Master Plan.

• Assure the provision of accurate, submission ready stability data information that is in compliance with market specific Health Authority.

• Identification of any issues that may result in stability related non-compliance with GMP, regulatory requirements or commitments.

• Maintenance and update of storage life records within S-Life.

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.

Servicio de empleo de origen: Arbetsförmedlingen, Servicios Públicos de Empleo, Suecia.

País del trabajo: Suecia.

Región: Stockholms län.

Ver 951 ofertas de trabajo en "Stockholms län" (Suecia).

Fecha de inicio: 01/06/2018.

Nº de vacantes: 1.

Experiencia: No se precisa.

Nivel educativo requerido: Sin especificar.

Carnet de conducir: No.

Horas semanales: Heltid Tillsvidare.

Tipo de contrato: Jornada completa.

Duración del contrato: Indefinido.

Cómo solicitar: Otros (véase la descripción).

Cómo solicitar el puesto: Sofie Önnestam titel : telefon 1: () telefon 2: () mobil: e-post: sofie.onnestamdfind.se

Link to the vacancy on the Swedish job board

Empresa: Dfind Science & Engineering AB.

Dirección: Regeringsgatan 65 10724 STOCKHOLM.

Contacto: Sofie Önnestam titel : telefon 1: () telefon 2: () mobil: e-post: sofie.onnestamdfind.se

Ver las 41 ofertas de trabajo de Profesionales científicos e intelectuales : Profesionales de las ciencias y de la ingeniería : Físicos, químicos y afines : Químicos ofertadas.

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