Qualified Person, Quality

About the role

West Pharmaceutical Services is hiring a Qualified Person (QP) in Quality in Dublin. The QP confirms disposition of human medicinal products and Investigational Medicinal Products (IMP) assembled, released and shipped to the Marketing Authorisation Holder, and acts as the EU site of batch release for products assembled, labelled and secondary packaged at the site. The role reports to the Director, Quality, is hybrid (on-site three days per week) and carries no relocation assistance.

Key responsibilities

• Certify batches of human medicinal products and imported batches against EU Directives 2001/83/EC and 2003/94/EC and Eudralex Volume 4 Annex 16, and confirm that each batch complies with its marketing authorisation and EU GMP.
• Make release decisions after reviewing batch files, the quality management system and manufacturing/testing processes, and assessing deviations and out-of-specification investigations.
• Ensure the QMS at the site meets GMP and regulatory requirements for batch certification, including supply chain mapping, risk assessments and supplier approval.
• Review QP confirmation documents from the MAH or manufacturer and advise on regulatory compliance, QMS, deviations, validation and other technical matters.
• Communicate with the customer, MAH, HPRA and other regulators, assist with regulatory inspections and follow up corrective and preventive actions.
• Stay informed on regulatory updates, QMS performance and emerging quality risks, attend the quarterly and management reviews, and comply with site EHS and company policies.

Required profile

• Meets the requirements of EU Directive 2001/83/EC Article 49 and EU GMP, including IMP requirements.
• 4-year degree in pharmacy, chemistry, biology, microbiology or equivalent.
• HPRA-recognised postgraduate qualification to act as QP (e.g. Graduate Diploma in Pharmaceutical Manufacturing Technology at Trinity College, RCSI or UCC) if the primary degree is not Pharmacy.
• Preferred: previously named on an HPRA medicinal manufacturing licence, at least 5 years' quality experience at a pharmaceutical manufacturer, and experience hosting regulatory inspections.

Required skills

• Knowledge of and experience setting up and maintaining a QMS for human medicines in the EU and USA.
• Understanding of regulatory requirements for combination products and experience in product safety and quality risk management.
• Good written and verbal communication, organisation and attention to detail.

What we offer

• Annual base salary range of EUR 81,900 to EUR 104,200, with possible variable compensation and benefits depending on location and employment status.
• Training, tuition assistance, leadership development and career opportunities across North America, Europe and Asia-Pacific.
• Volunteerism programmes, recognition and rewards, and an inclusive culture.