We are looking for a Quality Engineer for the QC department

We are looking for a Quality Engineer for the QC department

Are you a Engineer and ready to take the next career step? Then we have the perfect opportunity for you to join us as a QC Validation Engineer in our production unit in Halden. The main execution and implementation of new instruments and systems at the quality control laboratory in Fresenius Kabi Halden according to regulatory and corporate requirements for qualification and validation and good data management.

This is a 12 months temporary assignment.

Responsibilities / Duties

• Write qualification validation documents and protocols (e.g., URS, DQ, FRS and IQ/OQ/PQ) for laboratory equipment and systems. 
• Perform qualification and validation of analytical activities for instruments and computer systems to ensure compliance and functionality.
• Conduct periodic review of software systems and critical equipment.
• Support and responsible for investigation of QC deviations related to computerized systems and equipment’s according to applicable procedures and timelines. 
• Validate system and equipment in QC Lab.
• Execute change control, event handling and CAPA/ action management processes in compliance with the global QM 
• Implement and adhere to all relevant QM documents for qualification, validation and data management.

Qualifications

• Education from university in Chemistry/ Biotech/ Pharmacy/ Microbiology equivalent to Bachelor/Master or experience from equivalent position
• Knowledge and experience in Quality Control, Pharmaceutical industry, regulatory guidelines and regulations, Good Manufacturing Practice/21CFR part 11/Annex 1/GAMP5
• Experience in computer system validation, GAMP5, Data Management and Data Integrity is an advance
• Collaboration and capacity to work cross functional/ sites/ cultures
• Drive change, transparent and communicate clearly
• Fluency in English

Personal characteristics

• Positive mind-set and an including attitude
• Ability to build good relationships
• Ability to work in a structured, systematic and dynamic environment
• Good communication- and cooperation skills
• Proactive and goal oriented
• Organized and quality oriented
• Ability to make decisions

What can we offer?

• Creative work that will not let you get bored.
• A healthy work-life balance with flexible working conditions.
• Excellent pension and health insurance schemes.

Please contact Laima Kasiulis if you have any questions related to the position: laima.kasiulis@fresenius-kabi.com

Applicants will be considered on an ongoing basis.