Senior Analyst, OSS Compliance managing open - source software assets for The Hartford. Ensuring compliance and visibility into OSS usage as part of software asset management process.
About the role
- Quality Compliance Officer ensuring compliance with Good Distribution Practices in healthcare distribution. Supporting regional clusters in pharmaceutical and medical device regulatory adherence and quality assurance.
Responsibilities
- 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.
Job title
Job type
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Not specified
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