Position is responsible for the quality oversight of distribution of company products world-wide. Position will execute QA Distribution release of batches at 3PL Distribution centers, ensuring that product shipments are managed in compliance with GDP requirements and applicable company procedures. Position supports the company’s Logistics, Customer Operations and Commercial Distribution functions and in addition provides Quality Management System support to the site for managing quality records.
• Responsible for QA oversight of cold chain activities in all markets in accordance with local and international requirements and Alexion planning schedules; ensure products shipments are managed in accordance with GDP’s requirements.
• Ensuring QA distribution batch release of shipments at the 3PL Distribution centers.
• Assess cold chain shipments and provides corresponding quality decision on product.
• Review documentation including change controls, deviations, validation documentation, SOPs and specifications.
• Ensure Quality Agreement with the company’s distribution contractors and carriers are established and maintained.
• Assess and process product returns in conjunction with the company’s Logistics team.
• Provide Quality and compliance support to projects impacting site activities.
• Degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering.)
• 3+ years QA experience in a HPRA/FDA/EU & GDP regulated environment.
• Knowledge of Cold Chain activities.
• Knowledge of GDP and global regulatory requirements.
• 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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