Quality specialist QA

Job Description Summary

As an authorized Qualified Person you will certify that each batch of medicinal product that has been manufactured and released for sale, is safe for use and manufactured in accordance with Good Manufacturing Practice (GMP) guidelines and marketing authorization. You will undergo extensive training/qualification to qualify for the QP authorization by NoMA.

GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Job Description

We offer you opportunity to

• Attain a life-long expertise in the field of pharmaceutical manufacturing.
• Learn from Qualified Persons with long experience.
• Learn how to manage deviations, complaints, corrective & preventative actions (CAPA), Product Quality Reviews (PQR), Equipment Qualification and Process Validation activities.
• Learn how to work with digital platforms like SAP, LIMS, Maximo, Digital Batch Records, Veeva, and TrackWise Digital.
• Gain insight and experience in LEAN working principles.
• Gain insight and training in planning, performing and reporting in-house audit inspections.
• Create, modify, review and complete Standard Operating Procedures (SOPs).
• Participate in audits executed by national & international regulatory bodies like the Norwegian Medicines Agency (NOMA) & FDA.
• Be a part of our sociable and highly competent working environment.
• Prepare yourself well for leadership and the position of Qualified Person.

Upon authorization by NOMA, you will

• Become a member of our Qualified Persons team that currently certify the release of Active Pharmaceutical Ingredients (APIs), Aseptically prepared and Terminally sterilized pharmaceuticals, Investigational Medicinal Pharmaceuticals for clinical phase trials or Positron Emission Tomography (PET) products for cancer diagnostics.
• Participate in Drug Product Development projects with the goal of releasing new drugs to the market.
• Authorize and endorse Standard Operating Procedures for department use.
• Plan, participate and report audit inspections performed on international suppliers.
• Certify the release of GMP manufactured medicine batches to the global market.
• Train & teach GMP in our departments. 
• Complaint handling

  Qualifications/Requirements

• Master’s degree in Pharmacy (MSc. Pharm or Cand.Pharm), approved by the Norwegian Department of Health
• Oral and written proficiency in the Norwegian language
• Practical experience in pharmaceutical manufacturing is valued but not essential.

• To be successful in this position you should

• Fulfill the criteria presented in the qualifications section above
• Enjoy systematic, analytical, critical and adaptive work processes.
• Enjoy working in an interdisciplinary team environment.
• Enjoy upholding quality standards that promote good pharmaceutical manufacturing and documentation practices.
• Be dependable, reliable and willing to make holistic and pragmatic decisions in a timely manner.
• Enjoy managing several activities simultaneously and to deliver results within given time frames.
• Be legible for QP authorization within 2 years.

• Inclusion and Diversity

  GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

  Behaviors

  We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

Additional Information