Modis Life Science

Quality Assurance Advisor with Validation experience

Modis Life Science is looking for a Quality Assurance Advisor with Validation experience to AstraZeneca in Gothenburg! The Consultant assignment will start as soon as possible and proceed until 2019-12-31. Welcome with your application no later than 2018-06-10!
Upprättad
Ansökningsfrist
den 5 juli 2018
Anställningsförhållanden
Frilans
Antal timmar
Fulltid
Anställning
Tidsbegränsad
Region
Sverige > Mölndals stad > Västra Götalands län

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. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.

The arena:

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 Quality Advisor with GMP focus 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 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. 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:

In your role you will have interactions with internal and external stakeholders as well as with vendors and suppliers.

  • Provide QA advice into validation activities         
  • Provide QA advice into internal/external manufacturing activities of Drug Product and patient medication        
  • Perform 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, complaints, changes and other quality and compliance decisions in the development projects        
  • Provide QA support to pharmaceutical development project with interpretation of GMP regulations        
  • Provide appropriate QA input to business improvement projects       
  • Collaboration with AstraZeneca QA colleagues globally

The role may also include:

  • Responsible for QA advice and approval of documentation related to manufacturing equipment and facilities to ensure compliance, including validation, calibration, maintenance and change control.        
  • Interpret, trend and report compliance data, to measure and improve quality standards within the pharmaceutical development functions.        
  • Develop 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 with at least 3 years´ experience of working within a pharmaceutical GMP environment        
  • Broad understanding of validation 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

Preferred requirements:

  • Experience preferably within the area of validation         
  • Good team working and networking skills        
  • Capable of making effective decisions        
  • Demonstrate a high degree of personal credibility

About Modis:

We are constantly striving to support our customers and consultants to become successful. As a consultant, you are our top priority and when you need us, we will be there for you. We will include you in our business and to our customers. You are our most important asset and for us to stay ahead you will take an active part in our business development and our offers to the market. By becoming our colleague, your daily life as a consultant will be shifting with different assignments and projects in a variety of industries, systems and environments. Your experience will increase as well as your social and professional network. As a consultant, you are covered by collective agreements, insurance, occupational healthcare, healthcare and discounts on training cards. We believe in connecting people so having regularly social activities is key for us. Modis delivers a wide range of services and competencies within IT, Engineering and Life Science. Our services are characterized by speed, simplicity and quality. Modis is represented in the United States, Canada, Europe with over 100 offices and with more than 35,000 colleagues on assignments each day.

Arbetstid / Varaktighet

Konsultuppdrag


Skicka din ansökan

Are you interested?

Then you should apply as soon as possible. The position is soon to be filled and therefore work with recruitment is being done on a continual basis.
If you have questions regarding the position please contact:

Nalin Yilmaz nalin.yilmaz@modis.se 0736 847051

Anneli Bermbeck anneli.bermbeck@modis.se 0736 848333

Anders Olsson  anders.olsson@modis.se 0736 847248

Lilian Lawson lilian.lawson@modis.se 0736 928658

We look forward to your application!



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