A QA Distribution Specialist is required for a biopharmaceutical company in West Dublin. The incumbent will be responsible for the quality oversight of the distribution of products world-wide. The candidate will ensure product shipments are managed in compliance with GDP requirements and applicable company procedures. This position will 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 company planning schedules; insure 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.
- Ensure Quality Agreement with company’s 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.
Qualifications & Experience:
- Degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering).
- 5+ years QA experience in a HPRA/FDA/EU & GMP/GDP regulated environment.
- Thorough knowledge of Cold Chain activities.
- Thorough knowledge of cGMPs/GDPs and global regulatory requirements.
- 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.
To apply for this job email your details to firstname.lastname@example.org.