Since their founding they have focused on putting the patient first and this remains their priority as they continue to develop, acquire and commercialize new treatment options for patients with challenging conditions that no one else is tackling. Currently employing over 1000 staff globally with offices in the U.S. and Europe. They are a continually growing company with a broad portfolio, this position is based in their EU headquarters in Dublin.
- Managing the product stability programme.
- Investigating out-of-specification (OOS) reports & deviations.
- Act as lead auditor in third party vendor audits, to include: GMP contract manufacturing, analytical testing, and storage locations when required to ensure compliance within the business and country specific regulations.
- Monitor the operations at the Contract Manufacturer. Perform batch review, review product complaints, deviations, change controls and product related investigations.
- Be a key member of company audit team during regulatory or customer audits.
- Support the product complaints system.
- Operate the CAPA system.
- Develop and write SOPs & controlled documents.
- Implement and improve Quality Systems to realize the highest quality standards attainable for all activities conducted by the company.
- Report Quality Metrics.
- Assisting in preparation of Annual Product Reviews.
- Build authentic relationships and participate in business meetings, as required, with suppliers and contract manufacturers and maintain all product-related, Quality Technical Agreements (QTA’s).
- The incumbent should have a Bachelor’s degree in chemistry, biology or a related discipline.
- Experience working in finished product pharmaceutical / biologics, including analytical chemistry, quality assurance, quality control, development, and /or manufacturing areas.
- Experience with third party vendor auditing, out of spec investigations, change control.
- Thorough understanding of quality systems and cGMP’s.
- Interpersonal skills and professional skills to interact at all levels including senior executives, contractors, and colleagues.
- Experience working with contract manufacturing.
- Experience interfacing with regulatory bodies or working on regulatory submissions.
To learn more apply online or contact Preneta Naidoo on +353 1 6321870.
Salary: On Application
Location: Dublin City Centre