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.
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