QC Chemistry Compliance Officer (Stability and Reference std.)

at  GE Healthcare

JOB DESCRIPTION SUMMARY

The Chem. #3 Quality Control Department, Oslo Site, consists of 19 employees with different background within chemical analysis and GMP Compliance. The department is responsible for the in- process and release analysis of the aseptic products, establishment of testing regime for new raw materials related to the NPIs, stability, reference standards and the related compliance within QC Chemistry area at the Oslo Site.
QC Chemistry #3 is one of 6 QC Departments organized within the QO area.
As the company is currently growing and developing QC is looking to improve and strengthen the project team within the QC Chem. organization.

REQUIRED QUALIFICATIONS

• Bachelor’s level within Chemistry or equivalent
• Experience with handling of quality documentation.
• Experience from quality control, manufacturing, or quality assurance from the pharmaceutical industry.
• Excellent verbal, and written communications skills, flexible attitude.
• Norwegian and English skills.

• Responsible for coordination, implementation, and reporting of post approval/ annual/ follow up stability testing.
• Responsible for writing/ updating SOPs, protocols, reports related to stability testing.
• Responsible for change controls, deviations and CAPAs related to stability testing and reference standards.
• Responsible for making sure all established documentation is in compliance with current regulations as the different pharmacopeias and current GMP regulations.
• Responsible for writing of CoAs
• Follow up reference standards with regards to inventory, expiry and retest date.
• Responsible for dispensing, packing and shipment of reference standards.