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Senior QA Logistics Specialist
7 maanden geleden
Overview
Responsible for the following Territories: Licences established in the Netherlands with supply and distribution into the EMEA region as well as import and export activities.
Youparticipate in the compliance with GDP/GDP-API & GMP requirements for the distribution of Medicinal Product (e.g., Drug Substance/Drug Product/Finished Product/QP Certified Finished Product) into the EMEA region as well as import and export activities.
Responsibilities
Ensure all aspect of Kyowa Kirin’s Quality Management Systems (QMS) are applied to medicinal product distribution activities: Actively contributes to activities under the responsibility of the GDP Responsible Person, the Designated Person for API and the QP for distribution of Drug Substance(s)/Drug Product(s)/Finished Product(s)/QP Certified Finished Product(s). Execute supplier and customer verification management (e.g., onboarding/offboarding, contractor risk assessment, Bona Fide and Quality Technical agreement(s)). Executes Quality Assurance of Stock management (e.g., QA oversight of Inbound/Outbound, non-conformities, returns, stock reconciliation and destruction) with no delay to QA in close contact/cooperation with internal (e.g. SC/ finance) & external stakeholders (3PL(s)/customer(s)) Drives the monitoring of the distribution contractors’ quality performance according to a set of defined metrics with periodic reporting and proposes actions/improvement where applicable. Drives continuous improvement activities of the established QMS to support continuous compliance with the established licences. Executes implementation of Kyowa Kirin QA Global Policies and Global/Regional Procedures/Documents relevant to distribution activities. Ensure prompt and professional communication (including proposals for steps forward) of key issues to senior management as required to ensure effective collaboration towards compliant resolution of issues relating to licence compliance, supply and distribution of product. Actively participates in project management meetings to ensure the progress of ongoing tasks and to recognize and rectify any deficiencies in distribution-related activities Lead internal & contributes to external audits to assess adherence to GMP/GDP/GDP-API product distribution requirements and Kyowa Kirin QA Policies/Procedures. Raises appropriate change controls following quality risk management principles to ensure the change is compliant with applicable distribution/supply GDP/GMP regulations and the related QMS policies and procedures. leads investigations of distribution/supply non-conformities, deviations and temperature excursions and ensure appropriate CAPA are identified and implemented. Work closely with relevant stakeholders internally and externally: Internally e.g., members of cross functional groups in Kyowa Kirin as appropriate (e.g., Supply Chain, Project Management, Regulatory Affairs, Pharmacovigilance, Medical and Business) Externally e.g., GDP contractors/service providers in the territory. Deliver training to staff, as required.
Qualifications
Degree in life science or equivalent with preference of a minimum of 3 to 5 years’ experience in GDP. Specialist knowledge and experience of pharmaceutical QMS processes and practices. Experience of working within the pharmaceutical industry operating in a Quality Assurance position at a manufacturing/distribution site. Excellent working knowledge of GDPs for the distribution of commercial medicinal products Effectively working with cross-functional teams at a local and regional level. Good technical writing and editing skills. Fluent in English language and good level of Dutch - both verbal and written.Physical Requirements: (travel, lifting, typing, driving, sitting, special requirements around hours etc.)
As this can be a sedentary position the individual needs to be able to withstand long periods of sitting. Ability to use VDU equipment, read and focus intently for long periods of time. A degree of flexibility needed with regards to rare occasions where working late/early might be required. Limited travelling (local and international) might be needed for internal/external meetings.Key Competencies specific to the role: (what traits or capabilities must they have to succeed, examples include presentation skills, attention to detail, capability to influence and negotiate).
Kyowa Kirin Core Competencies: Results Oriented, Sense of Urgency and Flawless in Execution. Takes responsibility for ensuring key deliverables. Good interpersonal and communication skills. Good analytical and problem-solving skills. Team working. Self-starter with a good eye for detail and ability to complete tasks/objectives. Ability to operate in a “virtual” pharmaceutical environment.
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