Quality Assurance
Dfind Science & Engineering AB / Apotekarjobb / Göteborg
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Quality Assurance Advisors at AstraZeneca
Are you interested in a challenging opportunity within Quality Assurance, for one of the world's leading pharmaceutical companies?
We are now looking for Quality Assurance Advisors for one year consultant assignment. The Quality Assurance (QA) Advisor role has a broad range of responsibilities to ensure that activities and processes in Pharmaceutical Development functions and the R&D supply chain comply with Regulatory requirements, Good Manufacturing Practices and AstraZeneca internal quality system requirements. The role involves interactions with various internal functions and sites, but also with vendors and suppliers.
Business: Dfind Science & Engineering
City: Göteborg
The arena
Pharmaceutical Development is the function within AstraZeneca that designs and delivers the active drug product required to support new medicines. The Quality Assurance group within Pharmaceutical development now wants to take in Quality Assurance contractors with a Good Manufacturing Practice (GMP) focus. AstraZeneca's Pharmaceutical Development organization deals with all facets of the process of turning a new chemical entity (NCE) into a medicine which can be safely and effectively used by patients. The Quality Advisor role has a broad range of responsibilities to ensure internal and external requirements are fulfilled for AstraZeneca projects in the development phase. Interactions occur among various internal functions and sites, but also with vendors and suppliers.
The role
• In your work as a Quality Advisor at AstraZeneca you will have a broad range of responsibilities, the possibility to influence and to contribute to the pharmaceutical development function, and the delivery of our pipeline of exciting new medicines.
• Provide QA advise into Pharmaceutical Development internal/external manufacturing activities for Drug Product
• QA release of internally/externally manufactured and packed Drug Product as part of the Supply Chain to clinical trials
• Support the Pharmaceutical Development functions with investigations of deviations and other quality and compliance decisions having a major impact on AstraZeneca development projects
• Provide Pharmaceutical Development projects with QA support, such as GMP risk assessment and interpretation of GMP regulations
• Provide appropriate QA input to business improvement projects
• Close collaboration with AstraZeneca QA colleagues globally
The role may also include
• Responsible for QA approval of documentation related to manufacturing equipment and facilities to ensure compliance, including maintenance, calibration, validation and change control
• Interpret, trend and report compliance data, to measure and improve quality standards within Pharmaceutical Development.
• Developing QA Agreements with suppliers or contractors delivering services or products to the Pharmaceutical Development Supply Chain.
Minimum requirements - Education and Experience
• MSc in pharmacy or engineering (specializing in Pharmaceuticals) with at least 3 years' experience of working within a pharmaceutical GMP environment
• Broad understanding of Quality Systems and GMP
• Comprehensive understanding of the pharmaceutical/drug development process
• Good communicator with experience of interacting effectively across interfaces
• Fluent in written and spoken English as well as good skills in written and spoken Swedish
• Preferred requirements
• Experience preferably within a pharmaceutical manufacturing organization
• Good team working and networking skills
• Capable of making effective decisions
• Demonstrate a high degree of personal credibility
Personal Qualities
We put high importance in personal qualities. Candidates should possess good social skills and be strong team players. You should be able to work independently, take own initiatives and have a positive, goal oriented and problem solving attitude. It is essential to have good organizational and communication skills.
Deadline for applications: 2017-05-26 but please apply as soon as possible since selection and interviews are performed continuously.
More information: Birgitta Nyström
birgitta.nystom@dfind.se [ mailto:
birgitta.nystom@dfind.se ] or Eleonor Ehrman 0733-434109
Organization/Business description:
Dfind Science & Engineering är ett konsult- och rekryteringsföretag som erbjuder en omväxlande karriär som konsult inom teknik och naturvetenskap.
Hos oss har du möjlighet att utveckla dina kunskaper och bygga CV genom olika uppdrag hos våra utvecklings-, forsknings- och produktionsintensiva kunder samtidigt som du får stöd och vägledning från din konsultchef.
Vi är auktoriserade via Almega och följer deras kollektivavtal. Vi har dessutom förmåner som friskvårdsbidrag, företagshälsovård, försäkringar och rabatt på träningskort.
Välkommen till oss för en omväxlande och trygg karriär som konsult.
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2017-05-19ErsättningFast lön
Så ansöker duSista dag att ansöka är 2017-05-26
Ange följande referens när du ansöker: 201054667
Klicka på denna länk för att göra din ansökanKontaktEleonor Ehrman
eleonor.ehrman@dfind.seFöretagDfind Science & Engineering AB
AdressDfind Science & Engineering AB
Östra Hamngatan 23
41110 GÖTEBORG
KontorsadressÖstra Hamngatan 23, 41110 GÖTEBORG
Jobbnummer 3511255
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