QA specialist

MS0229 GE Healthcare AS; Oslo; On-site; NOK 700,000 - 900,000; Full time

Job summary

GE HealthCare in Oslo seeks a Quality Specialist to manage deviations, CAPAs, and complaint handling within Product Quality and SOP governance. The role involves authoring Product Quality reviews, updating SOPs, and coordinating compliance activities across sites, including collaboration with QP and department teams.

The candidate will support projects, engage in problem solving, and provide professional guidance to the plant and departments, including batch documentation support.

Qualifications

• Batchlor or master’s degree in pharmacy or equivalent
• Experience from pharmaceutical industry
• Experience from GMP work.
• Know your way around Office programs.
• SAP, Veeva, Trackwise, Digital, LIMS.

Responsibilities

• Handling of deviations and CAPAs
• Complaint handling
• Product Quality review (author)
• SOP handling (follow up TBR, updating of SOPs, coordination of SOP, review)
• Compliance Wire responsible person
• Support projects and problem solving
• Batch documentation (support to QP, follow up against department)

Skills

GMP experience

Office software

Education

Master's degree in Pharmacy

Bachelor's degree in Pharmacy

Tools

SAP

Veeva

TrackWise

LIMS

Digital

Job description

Job Description Summary

Quality specialist. Main task: Handling of deviations and CAPAs Complaint handling Product Quality review (author) SOP handling (follow up TBR, updating of SOPs, coordination of SOP, review etc. Compliance Wire reseponsible person Support projects. Participate in problem solving and be a professional support for the plant and departement. Batch documentation (support to QP, follow up against department)

Job Description Department QA DABR

Main tasks: Handling of deviations and CAPAs Complaint handling Product Quality review (author) SOP handling (follow up TBR, updating of SOPs, coordination of SOP, review etc. Compliance Wire reseponsible person Support projects. Participate in problem solving and be a professional support for the plant and departement. Batch documentation (support to QP, follow up against department)

Qualifications

Batchlor or master’s degree in pharmacy or equivalent Experian’s from pharmaceutical industry Experience from GMP work. Know your way around Office programs. SAP, Veeva, Trackwise, Digital , LIMs.

Professional Traits

Solution oriented – the favorable candidate is one who identifies a problem, identifies and propose solutions, finds the relevant facts before asking for presenting and asking for assistance. Structured – enjoys setting goals, timelines and achieving them promptly. Positive – An attitude that invites collaboration and makes the process of achieving difficult/complex tasks, enjoyable. Social – ability to interact with others regardless of ethnicity, religion, gender, political views, or personal world view. Enjoys working with experts from other fields including Quality Control analysis, Manufacturing, Packaging, Research & Development, Regulatory affairs, Artwork Management, Suppliers and Authorities around the world. A teachable spirit – the ideal candidate identifies the complex nature of drug manufacturing and its implications to human life. Moreover, being sober and clear about the things one does not understand and the willingness to critically ascertain the information one perceives as the truth is a critical part of being suitable for this job. Team members including leader – 18. Gender distribution – 17 female and 1 male Age distribution – 29 – 67 years Average education – master’s degree in pharmacy Experience in GE – 1-30 years Common behavioral attributes– Analytical, Social, Integrity, High work capacity, Service oriented, High delivery. Work environment in the department is generally at a high pace. QP release of products to the market. I addition a range of activities from drug development, upscaled production, technical transfers, to manufacturing and product discontinuation.

Role Overview

The Correct candidate to this position will work together with the QPs The candidate will work with routine activities that are very important to serve the market with products. candidates which have succeeded in the past have been solution oriented, hardworking, show a high level and analytical aptitude, enjoy upbeat work environments and cross-functional cooperation with other departments, sites (Cork & Shanghai) and world (Suppliers and customers all over the world)

Position Status

It is a temporary position (Maternity leave) but might be a permanent position. It is not possible to say at the present time It depends on the qualification and the business need.

Additional Information

Relocation Assistance Provided: No

Company

At GE HealthCare, we see possibilities through innovation. We’re partnering with our customers to fulfill healthcare’s greatest potential through groundbreaking medical technology, intelligent devices, and care solutions. Better tools enabling better patient care. Together, we are not only building a healthier future but living our purpose to create a world where healthcare has no limits.