Qualified Person

Morgan McKinley; Munster; Vor Ort; EUR 70.000 - 110.000; Vollzeit

Zusammenfassung

Morgan McKinley is partnering with a well-established SME pharmaceutical business in Ireland to appoint a Qualified Person (QP) to join its site Quality team. The role involves ownership of batch certification and release, contributing to continuous improvement, and driving a culture of quality across the business.

You will ensure compliant batch certification, maintain robust QMS, and work with cross-functional teams to uphold regulatory standards.

Qualifikationen

• Accredited degree in Pharmacy or relevant science with regulatory postgraduate qualification.
• At least 2 years of industrial experience as a Qualified Person in a pharmaceutical manufacturing environment.
• Experience with batch certification, release and Quality Management Systems.
• Knowledge of CAPA, Deviations, Change Control, Risk Assessment and OOS investigations.
• Willingness to work on-site to provide effective quality oversight and engage cross-functionally.
• Strong written and verbal English communication; able to build relationships across the organization.

Aufgaben

• Act as a registered Qualified Person on the site licence, certifying and releasing batches per EU GMP and regulatory standards.
• Drive and improve Quality Systems including Change Control, Deviations, CAPA, QRM and OOS investigations.
• Ensure manufacturing, packaging and testing align with Marketing Authorisations and EU GMP requirements.
• Review and approve batch records and quality documentation prior to release.
• Lead root-cause analyses and risk assessments related to quality issues and batch discrepancies.
• Collaborate with Manufacturing, Quality Control, Supply Chain and Regulatory Affairs to uphold quality and compliance.
• Support regulatory inspections and customer quality audits to demonstrate compliance and a strong quality culture.
• Partner with the Head of Quality on day-to-day quality matters and continuous improvement.

Kenntnisse

Quality oversight

Regulatory compliance

Root cause analysis

Cross-functional collaboration

Attention to detail

English communication

Ausbildung

University degree in Pharmacy or relevant science

Postgraduate regulatory qualification

Jobbeschreibung

Are you an experienced Qualified Person looking for a role where you can make a genuine difference, have a voice in the business, and build a long-term career?

We are partnering with a well-established SME pharmaceutical business to appoint a Qualified Person (QP) to join its site Quality team.

This is an opportunity to join a business where people genuinely matter. With a friendly, welcoming and collaborative culture, the organisation benefits from a number of long-serving team members who have built their careers within the business. There is a strong sense of teamwork, and individuals are encouraged to contribute, challenge constructively and have a meaningful influence on how the business operates.

Reporting directly to the Head of Quality, you will play a key role in day-to-day quality operations, taking ownership of batch certification and release while working closely with colleagues across Quality and the wider business. You will have broad exposure to quality activities, the opportunity to contribute to continuous improvement, and the scope to develop your career towards more senior quality management and site leadership responsibilities over time.

For someone seeking more than just their next move, this is an opportunity to find a business where you can build lasting relationships, grow professionally and make a tangible contribution.

The Role

As the Qualified Person, you will be responsible for ensuring compliant batch certification and release, maintaining robust Quality Management Systems, and supporting a culture of quality and continuous improvement across the business.

Key responsibilities will include:

• Act as a registered Qualified Person on the site licence, legally certifying and releasing batches in accordance with EU GMP requirements and applicable regulatory standards.
• Drive, maintain and continuously improve Quality Systems, including Change Control, Deviations, CAPA, Quality Risk Management (QRM) and Out of Specification (OOS) investigations.
• Ensure manufacturing, packaging and testing activities are conducted in accordance with the relevant Marketing Authorisations (MAs), EU GMP requirements and applicable regulatory standards.
• Review and approve batch manufacturing records and associated quality documentation to ensure compliance and product quality prior to release.
• Lead and contribute to root-cause analysis, risk assessments and investigations relating to quality issues and batch discrepancies.
• Work collaboratively with Manufacturing, Quality Control, Supply Chain, Regulatory Affairs and the wider team to maintain high standards of quality, compliance and operational performance.
• Support regulatory authority inspections and customer quality audits, helping to demonstrate a robust state of compliance and a strong quality culture.
• Partner closely with the Head of Quality and the wider Quality team on day-to-day quality matters, continuous improvement initiatives and the ongoing development of processes.
• Actively contribute to a positive, proactive and collaborative quality culture, ensuring that quality remains central to business decisions.

About You - You will ideally bring:

• An accredited university degree in Pharmacy or a relevant science degree combined with a specialised, regulatory-approved postgraduate qualification.
• A minimum of two years' industrial experience acting as a Qualified Person within a pharmaceutical manufacturing environment.
• Proven experience in pharmaceutical manufacturing, batch certification and release, and Quality Management Systems.
• Strong knowledge and practical experience of core quality processes, including CAPA, Deviations, Change Control, Risk Assessment and OOS investigations.
• The ability and willingness to work on-site to provide effective quality oversight and engage closely with cross-functional colleagues.
• Excellent attention to detail, sound judgement and a high degree of personal accountability, integrity and decisiveness.
• Strong written and verbal communication skills in English, with the ability to build effective relationships across all levels of the organisation.
• A collaborative mindset and the confidence to contribute ideas, challenge where necessary and work constructively with colleagues to achieve the right outcomes.

If you are an experienced QP seeking a role where you can combine technical responsibility with genuine collaboration, professional development and the opportunity to make a lasting impact, we would welcome a conversation.