Title:  Qualified Person, Quality

Job Summary

The Qualified Person (QP) will have responsibility for making disposition decisions in relation to human medicinal products and Investigational Medicinal Products (IMP) that are assembled at West, released and shipped to the customer (the Marketing Authorisation Holder (MAH), for further processing. This disposition activity represents QP confirmation of partially manufactured Human Medicinal Products. Human Medicinal Products that are assembled, labelled and secondary packaged at Tech Group Europe Limited (t/a WEST) will be required to be batch certified by the West QP as the EU site of batch release. dIn addition, the QP will guide and support the Quality Team at West on all aspects of pharmaceutical regulatory compliance. Report directly to the Director, Quality.

Essential Duties and Responsibilities

• For medicinal products manufactured within the European Community that each batch has been produced and tested/checked in accordance with the relevant EU Directives and the Marketing Authorisation.
• For medicinal products manufactured outside the European Community ensure that each imported batch has undergone, in the importing country, the testing specified in paragraph 1 (b) of Article 51.
• Certify in a register or equivalent document, as operations are carried out and before any release, that each production batch satisfies the provisions of Article 51.
• To ensure that the batch has been manufactured and checked in accordance with the requirements of its marketing authorisation and the principles and guidelines of EU Good Manufacturing Practice.
• Comply with the duties and responsibilities defined in EU Directives 2001/83/EC and 2003/94/EC and Eudralex Volume 4 Annex 16: Certification by a Qualified Person and Batch Release and contained in a separate technical agreement.

• Have responsibility for making a release decision in relation to medicinal products assembled at West. This decision will be based on a detailed review of batch files and a detailed knowledge of the quality management system and of manufacturing and testing processes at West. The release decision will also be based on a risk assessment of any deviations, out of specification investigations etc. associated with the batch.
• Have responsibility to batch certify human medicinal products assembled, labelled and packaged at West. This decision will be based on a detailed review of West batch files and batch files from the site of drug product manufacture (where applicable) and a detailed knowledge of the quality management system and of the manufacturing and testing processes at West. The release decision will also be based on a risk assessment of any deviations, out of specification investigations etc. associated with the batch.
• Ensure the QMS in place at West to support West as a site of batch release meets all GMP and regulatory requirements for batch certification including supply chain mapping, risk assessments ad supplier approval processes.
• Review documentation and release certificates for QP confirmation provided by the QP at the MAH/manufacturer of the medicinal product which is to be assembled into the drug delivery device at West. 
• Provide advice on regulatory compliance in relation to the Quality Management System, deviations or other anomalies which could impact on the safety and compliance of medicinal products, validation requirements and on other technical matters, as requested. 
• Communicate with the customer, MAH, HPRA and other regulatory authorities, as necessary.
• Assist with preparation for regulatory inspections, participate during inspections, agree responses to regulators and advise and follow up on corrective and preventive actions until close out.
• Remain well-informed on regulatory updates for example by attending the annual QP forum, interpreting regulatory drafts or submission to understand impact on West operations.
• Remain informed about performance of the QMS and emerging quality trends and risks such as complaints, audit findings, deviations, non- conformances etc.
• Ensure attendance at West’s quarterly review and West’s management review as it relates to medicinal product.
• Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
• Compliance to all site Environmental, Health and Safety requirements, training, and regulations.
• Compliance to all local site company policies, procedures, and corporate policies.
• Perform additional duties as assigned

Education

• Meet the requirements of EU Directive 2001/83/EC Article 49 as amended and EU GMP including IMP requirements
• Hold a 4-year degree programme in pharmacy, chemistry, biology, microbiology or equivalent  
• Hold a HPRA - recognized postgraduate qualification from an approved university course to act as Qualified Person, such as the Graduate Diploma in Pharmaceutical Manufacturing Technology at Trinity College, RCSI or UCC, where the primary degree is not Pharmacy

Travel Requirements

What We Offer