Ownership and Accountability for the Management and oversight for effective product transfer of NPIs and transfer to commercial manufacturing processes.
Management of site QPs and Manufacturing Quality Assurance (MQA), including NPI and Commercial batch release, product performance and regulatory support.
Ensuring that sterile and aseptic products manufactured meet requirements of end users, Regulatory Authorities and of the company.
Verify that batches are manufactured and comply with the provisions of the marketing authorisation.
Ensure manufacture has been carried out in accordance with all applicable Good Manufacturing Practice, e.g., EU GMP Annex 1 and FDA regulations.
Ensure the principal manufacturing and testing processes have been appropriately validated; account has been taken of the actual production conditions and manufacturing records.
Confirm that any exceptions or planned changes in production or quality control have been authorised by the persons responsible in accordance with a defined system. Any changes requiring variation to the marketing or manufacturing authorisation have been notified to and authorised by the relevant authority.
Liaise with global Quality Assurance and Regulatory groups, FDA, HPRA and other Regulatory bodies (where applicable).
Responsibilities
Degree level qualification in a science discipline with previous experience in the healthcare/pharmaceutical industry.
M Sc in Industrial Pharmaceutical Science or similar course recognized by Regulatory Authority to permit Qualified Person (QP) status as per Article 49 of Directive 2001/83/EC
Industrial experience gained in a FDA and EMA approved pharmaceutical environment.
Previous supervisory and managerial experience in a manufacturing related area in a Biotechnology, Pharmaceutical or Medical Device organisation
Experience in manufacturing processes of drug product/substance, including aseptic filling, visual inspection of drug product, solutions preparation, and sterilization operations preferable.
Proven track record in audit management and regulatory interaction management.
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