ERP / Pharma

Senior Quality Analyst

Return to Postings

Our client are a leading pharmaceutical company who have a fantastic opportunity for a senior Quality analyst to join them in Sweden.

Posted On: Monday, 1st October 2018
Location: Sweden
Job Type:
Contract
Education: Graduate Degree
Pay Rate: €45 - €80 per hour
Duration: End of the year then long term extension
Travel:

Job Description:

Our client are a global biopharmaceutical company with a fantastic reputation for innovation and research they are now looking for a Quality Senior Analyst to join them in the Swedish city of Sodertalje just outside of Stockholm.

As part of your role you will expected to:

  • Provide quality assurance support to Sweden Operations and Operations 
  • Work according to the principles of LEAN and contribute with GMP knowledge to the improvement and the investigations of anomalies.
  • Participate as an expert related to GMP requirements for computerized systems in preliminary studies for new investments primarily in production
  • Participate as a project member in validation projects, and thereby review and GMP approve associated documentation
  • In projects based on process knowledge, it is possible to propose improvements to working methods (digitization) to enable more effective management of work processes / automation / information management 
  • GMP assess deviation reports and investigations related to computerized systems and data (record) integrity

The service also includes:

  • Interpret and apply GMP requirements based on current quality system
  • GMP approve SOPs related to computerized systems
  • Follow developments in the field of computerized systems and validation and monitor and inform / educate about GMP in the field
  • Evaluate existing working methods, identify and drive improvements (LEAN)
  • Participate in internal and external inspections

You have the following qualifications:

  • Higher education or documented long experience in computerized systems
  • Depth and broad Good Manufacturing Practice (GMP) knowledge or experience of quality assurance in other industries governed by regulations
  • Knowledge of manufacturing processes and understanding of what is important for product and process
  • Broad knowledge in validation of equipment, process and computer systems
  • Broad technical skills and a good understanding of various technical architectures and applications
  • Good cooperative skills
  • Very good knowledge of Swedish and English
  • Knowledge of data integrity, data security and archiving of electronic information is ideal

Reasons to apply:

  • Our client have a well-established culture of operational excellence that exists and is promoted in the Swedish culture
  • Our client will accept English speakers if they meet the skill set.

Preferred Skills: