id: MDMzMTE5MDEwMDAzNzUgMjYx

reference: 03311901000375

documentId: 03311901000375

connectionPointId: 261

Stillingstittel:
GE Healthcare AS Production Oslo seeks candidates for the position of Qualified Person

Stillingsbeskrivelse:

Role & Responsibilities:

The main role of an authorized Qualified Person is to 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.

We offer the successful candidate the opportunity to;

• Attain a life-long expertise in the field of pharmaceutical manufacturing.

• Learn from Qualified Persons with up to 34 years' 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.

• 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, the candidate 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.

Qualifications/Requirements:

Master's degree in Pharmacy (MSc. Pharm or Cand.Pharm), approved by the Norwegian Department of Health

Oral & written proficiency in the Norwegian language

Practical experience in pharmaceutical manufacturing is valued but not essential.

To be successful in this position the trainee 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.

Benefits:

• Permanent position

• Competetive salary & remuneration package

• Access to free gym classes, vaccination and other health benefits.

• Excellent pension benefits

• Personal development & promotion opportunity in a global company

Se annonse

PAM

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2262

abstractJV_contact_0: See jobabstractJV_description

contractTypeCodes_0: fulltime

Arbeidsgiver Navn: GE Healthcare AS

source: NAV