This is a 9 month contract with a view to extension
The Senior Specialist, Quality Distribution position is responsible for the quality oversight of the distribution of products world-wide. The position ensures product shipments are managed in compliance with GDP requirements and applicable company procedures. The position support Logistics, Customer Operations and Commercial Distribution functions globally and is primary QA technical contact point with external distribution partners (distributors, carriers, suppliers).
• Responsible for QA oversight of cold chain activities in all markets in accordance with local and international requirements and planning schedules; ensure products shipments are managed in accordance with GDP’s requirements.
• Assess cold chain shipments and provides corresponding quality decision on product.
• Act as primary QA technical contact point with distribution partners. Provide guidance, drive and monitor Quality issues related to cold chain and GDP to resolution within the company and with external parties.
• Review documentation including change controls, deviations, validation documentation, SOPs and specifications.
• Provide Change Planning support and direction to GSC partners including but not limited to commercial product launches and key project schedules.
• Provided Quality technical support for the execution of validation & qualification activities relating to the company’s distribution network.
• Ensure Quality Agreement with distribution contractors and carriers are established and maintained. Support the conduct of Quality and Operations review meeting with Distribution contractors.
• Contribute to define and follow-up standard quality KPI and to review quality indicators with recommendation for actions for improvement in relation to GDP’s contractors
• Support the preparation of Health Authorities inspections and provide support for regulatory submissions.
• Degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering)
• Minimum 5 years Quality/ Compliance experience in a regulated environment
• Minimum 5 years’ experience in Good Distribution Practices including validation/ qualification of cold chain systems.
• Thorough knowledge of Cold Chain activities
• Thorough knowledge of cGMPs/GDPs and global regulatory requirements (HPRA/FDA/EU)
• International exposure in positions interacting with and influencing site operations
• Sound awareness and understanding of pharmaceutical and biotech business, especially with regards to quality and regulatory requirements
• Strong Interpersonal skills and ability to interact constructively with all functions in a matrix organization environment
• Good verbal and written communication skills with well-structured communication and ability to present to various audience levels
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