Norgine

Quality Compliance Officer – GDP

Norgine

full-time

Posted on:

Location Type: Hybrid

Location: Wettenberg • 🇩🇪 Germany

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Job Level

Mid-LevelSenior

About the role

  • The Quality Compliance Officer is responsible for providing support to the Regional clusters with regards to Good Distribution Practice (GDP) and product compliance related activities.
  • Quality oversight and overall responsibility on compliance of country Wholesale Dealers Licence with EUROPEAN COMMISSION Guidelines of 5 November 2013 on Good Distribution Practice of Medicinal Products for Human Use.
  • Act as Local Person responsible for Regulatory compliance and ensure the management and Quality Assurance of the distribution activities of the medical devices.
  • Ensure legal entity have Wholesale Dealers licences in place that are compliant with GDP expectations set in the EC Guidelines of 5 November 2013 on GDP of medicinal products for human use.
  • Ensure that Norgine’s regional clusters quality management systems is maintained, under RP/Quality affiliate oversight, focusing on the management of authorised activities and accuracy and quality of records.
  • Releasing of medicinal product and medical devices to the market from batches received in the warehouse from different supplier and prior to distribution.
  • Coordinate release activities with supporting GDP colleagues.

Requirements

  • A scientific degree is essential and suitability for immediate registration as a Responsible Person is mandatory
  • Sufficient experience to act as the responsible professional resource in field
  • Minimum of 3 years relevant pharmaceutical industry experience.
  • Experience auditing in GDP /ISO environments
  • Experience with regulatory and ISO inspections
  • Experienced in leading successful regulatory inspections.
  • Good knowledge of regulatory requirements impacting the pharmaceutical and medical device industries, in particular the pharmaceutical distribution environment with good knowledge of GMP/GDP.
  • Excellent influencing skills and ability to establish effective working relationships with personnel at Norgine or distribution partners.
  • Excellent verbal and written communication skills ability to present effectively to groups
  • Proven ability to use Quality Management Systems and KPI reporting to best advantage in support of compliance and continuous improvement.
  • Proven ability to make science based, data driven recommendation/decisions and take appropriate action.
Benefits
  • Our benefits may vary per location. Please liaise with the Norgine TA representative to obtain more information.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
Good Distribution Practice (GDP)Quality Management Systems (QMS)KPI reportingauditingregulatory inspectionsGMPISOdata-driven decision makingscientific degreeResponsible Person registration
Soft skills
influencing skillseffective working relationshipsverbal communicationwritten communicationpresentation skillsleadershipcollaborationproblem-solvingattention to detailcontinuous improvement