Quality Assurance Specialist

QA Specialist- Distribution - Republic of Ireland

A Leading Dublin based biotechnology organization requires a QA (Quality Assurance) Specialist to support their Global Distribution/ Shipping and logistics from their state-of-the-art manufacturing facility in line with regulatory standards and GDP (Good distribution Practice). 

 Position is responsible for the quality oversight of distribution of  finished products world-wide.

 Position will execute QA Distribution release of batches at 3^rd party  Distribution centres, ensuring that product shipments are managed in compliance with GDP requirements and applicable procedures. Position supports  Logistics, Customer Operations and Commercial Distribution functions and in addition provides Quality Management System support to the site for managing quality records. 

Responsibilities:

• 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.
• Ensuring QA distribution batch release of shipments at the 3rd party 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 distribution contractors and carriers are established and maintained.
• Assess and process product returns in conjunction with internal  Logistics team.

• Provide Quality and compliance support to projects impacting Distribution site activities.

 

Requirements:

• Knowledge of Cold Chain activities
• Knowledge of GDP and global regulatory requirements
• Sound awareness and understanding of pharmaceutical and biotechnology 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

• Degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering)

 

 
Please apply with your CV now for this contract opportunity for a chance to work with a growing global organisation on their expanding global distribution network. 

 



The candidate must have the rights to work in the location stated in the job advert.

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