QA specialist

Posted 10 Hours Ago
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Hiring Remotely in Oslo, NOR
Remote
Mid level
Artificial Intelligence • Healthtech • Analytics • Biotech
The Role
Perform QA activities for a pharmaceutical plant: manage deviations/CAPAs, complaints, author product quality reviews, maintain SOPs, support batch documentation, assist QP, support projects and problem-solving across departments.
Summary Generated by Built In
Job Description SummaryQuality 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.
  • 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.  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)

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

Skills Required

  • Bachelor's or Master's degree in Pharmacy or equivalent
  • Experience in the pharmaceutical industry
  • Experience with GMP work
  • Proficiency with Office programs (Microsoft Office)
  • Experience with SAP
  • Experience with Veeva
  • Experience with TrackWise
  • Experience with LIMS
  • Handling deviations and CAPAs
  • Complaint handling experience
  • Authoring Product Quality Reviews (PQR/PQR-equivalent)
  • SOP management: updating, coordinating, reviewing SOPs
  • Batch documentation support and follow-up with departments and QP
  • Ability to support projects and participate in problem solving
  • Compliance Wire responsible person duties
  • Solution-oriented approach
  • Structured and goal-oriented work style
  • Positive, collaborative attitude
  • Strong interpersonal skills (works well across functions and cultures)
  • Teachable spirit and willingness to learn complex drug manufacturing processes

GE Healthcare Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about GE Healthcare and has not been reviewed or approved by GE Healthcare.

  • Healthcare Strength Healthcare coverage is portrayed as comprehensive, including medical, dental, and vision options with HSA-eligible choices and preventive care coverage. Mental health and well-being support programs are also emphasized as part of the overall package.
  • Retirement Support Retirement support is described as meaningful, with a 401(k) match and additional programs such as student-loan matching in some descriptions. Legacy pension and retiree medical obligations for certain closed groups also signal continued support for long-tenured populations.
  • Strong & Reliable Incentives Variable and role-linked earning opportunities appear attractive in some job families, including high on-target earnings potential in certain sales roles. Additional role-based perks like company cars and travel-related reimbursements further increase the perceived value of total rewards in those positions.

GE Healthcare Insights

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The Company
Chicago, IL
50,282 Employees
Year Founded: 1892

What We Do

Every day millions of people feel the impact of our intelligent devices, advanced analytics and artificial intelligence. As a leading global medical technology and digital solutions innovator, GE Healthcare enables clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by its Edison intelligence platform. With over 100 years of healthcare industry experience and around 50,000 employees globally, the company operates at the center of an ecosystem working toward precision health, digitizing healthcare, helping drive productivity and improve outcomes for patients, providers, health systems and researchers around the world. We embrace a culture of respect, transparency, integrity and diversity.

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