Quality Assurance Specialist – Distribution is required by a biopharmaceutical company based in Dublin. The company is focused on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products.
The Quality Assurance Specialist – Distribution will be responsible for:
o Responsible for QA oversight of cold chain activities in all markets in accordance with local and international requirements; ensure products shipments are managed in accordance with GDP requirements.
o Assess cold chain shipments and provides corresponding quality decision on product.
o 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.
o Review documentation including change controls, deviations, validation documentation, SOPs and specifications relating to distribution activities.
o Contribute to the maintenance, review and update of Standard Operating Procedures for Quality Assurance and Distribution related activities ensuring compliance with GDP regulations.
o Contribute to defining standard quality KPIs and to review quality indicators with recommendation for actions for improvement in relation to GDP contractors.
o Support the preparation of Health Authorities inspections and provide support for regulatory submissions.
o Ensure that the operations do not compromise the quality of medicines by ensuring that systems are in place to monitor storage of the product through the supply chain under the control of the company.
o Ensure any subcontracted activities which may impact on GDP are approved and that suppliers and customers are approved.
Education, Experience and Skills
o Academic degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering)
o Responsible Person Certified desirable
o Minimum 5 years of experience in Quality Assurance distribution and Good Distribution Practices
o Previous experience in the capacity of a Responsible Person / Deputy Responsible Person an advantage
o Minimum 2 years in international pharmaceutical and/or biotech industry with increased level of responsibility
o Experience in working with a complex supply chain
o Experience with engaging, influencing and supporting market affiliates
o Previous experience in Shipping Validation an advantage
o Demonstrated success records in auditing and improvement processes
Call Kathy at LSC on 021 4777 329 for more information on this Quality Assurance Specialist – Distribution , or apply directly via this advert.