We are looking for a QC Engineer for our Micro Specialist group

Are you a Laboratory Engineer and ready to take the next career step? Then we have the perfect opportunity for you to join us as a Engineer QC Laboratory in our production unit in Halden, Norway within the QC Microbiology team.

The Senior Engineer will be an integral part of the specialist group in the QC-Microbiology department. The position works under the direction and supervision of the Specialist Group Team Lead. The successful candidate will analyze quality control data, such as test results, process non-conformances, audit reports, deviations, OOx, etc, to identify, correct and improve quality issues. The Senior Engineer will also be a key resource in identifying and implementing best practices for process improvements and problem solving.

Main Responsibilities

• Support a risk-based approach for the development, documentation, validation, implementation, maintenance, and enhancement of the departments processes such as release control, environmental monitoring, deviation handling etc.
• Review documentation (such as result records, procedures, work instructions, forms etc.) to ensure that they are accurate, complete, and compliant with the process and with the requirements of the quality management system / GMP.
• Review and approve test results
• Review and approve validation protocols and reports
• Investigate deviations and OOx results incl. impact assessments and root cause analysis
• Support change management activities (CAPAs) to ensure process changes are managed and approved effectively
• Perform Risk Assessments
• Assist and present at regulatory inspections and quality audits
• Work actively with maintenance and improvements of procedures, specifications, routines, and methods in accordance with cGMP, GDP and Pharmacopeias
  

Desired Qualifications

• The qualified individual should have a bachelor's degree in a scientific field such as Microbiology, Pharmacy, Molecular Biology. An advanced degree is preferred.
• Documented Experience from Quality work within Pharma industry
• Excellent communication, interpersonal and cooperation skills
• Have a good understanding of cGMP, GDP and Pharmacopeias.

Personal characteristics

• Positive mind-set and an including attitude
• Ability to build good relationships
• Proactive and goal oriented
• Organized and quality oriented

If you are interested to go on this journey with us, feel free to apply for this position!

Please apply before the 5th of February.

For more information about the position, please contact hiring Manager: Finn Terje Hegge, Mg QC Microbiology. Applicants will be considered on an ongoing basis.