Qualified Person (QP)

Pale Blue Dot®Recruitment Limited; Munster (IN); On-site; USD 80,000 - 125,000; Full time

Job summary

Pale Blue Dot®Recruitment Limited is seeking an experienced Qualified Person (QP) to join a senior Quality team in the Munster region. The successful candidate will certify finished product batches in line with GMP, regulatory requirements and site quality procedures.

Responsibilities include batch review, certification, and addressing deviations, CAPAs and change controls. The role supports regulatory inspections and QA systems development within a compliant manufacturing environment.

Qualifications

• Strong knowledge of GMP manufacturing and batch release.
• Experience in deviations, CAPA, change control and QA risks.
• Experience with HPRA or other authorities inspections.
• Experience operating in an Irish HPRA-regulated manufacturing environment.

Responsibilities

• Perform Qualified Person certification of finished product batches.
• Review batch manufacturing, packaging, testing and QA documentation prior to certification.
• Investigate deviations and OOS results and ensure appropriate CAPA.
• Provide QP input into deviations, CAPAs, change controls and investigations.
• Support regulatory inspections and GMP audits.
• Maintain documentation and records relating to batch certification and release.

Skills

GMP knowledge

Batch certification

Quality systems

Regulatory compliance

Cross-functional collaboration

Attention to detail

Strong communication

Education

QP status

Job description

Our client, an established pharmaceutical manufacturing company based in the Munster region, is seeking an experienced Qualified Person (QP) to join its Quality team.

The successful candidate will be responsible for the certification and release of medicinal product batches in accordance with applicable regulatory requirements, Good Manufacturing Practice (GMP), relevant Marketing Authorisations and the site's quality systems.

This is a senior quality position requiring strong knowledge of GMP manufacturing, batch certification and pharmaceutical quality systems.

Responsibilities include but are not limited to:

• Perform Qualified Person certification of finished product batches in accordance with applicable regulatory and GMP requirements.
• Ensure that batches have been manufactured, tested and controlled in accordance with relevant regulatory requirements, Marketing Authorisations and approved procedures.
• Review batch manufacturing, packaging, testing and associated quality documentation prior to certification.
• Ensure appropriate investigation and resolution of deviations, out-of-specification results and other quality events that may impact batch certification.
• Review and provide appropriate QP input into deviations, CAPAs, change controls and investigations.
• Support the effective operation and continued development of the site's Pharmaceutical Quality System.
• Provide quality and compliance guidance in relation to manufacturing, testing, packaging and release activities.
• Support regulatory inspections and internal and external audits as required.
• Work closely with Quality Assurance, Quality Control, Manufacturing and other functions to maintain ongoing GMP compliance.
• Support continuous improvement of quality systems, procedures and compliance processes.
• Ensure appropriate documentation and records relating to batch certification and release are maintained.
• Remain current with applicable GMP requirements, regulatory guidance and legislation relating to medicinal product manufacture and certification.

Job requirements

• Qualified Person status with the appropriate qualifications, training and practical experience required to act as a QP in Ireland.
• Previous experience carrying out QP responsibilities within a GMP-regulated pharmaceutical manufacturing environment.
• Strong working knowledge of EU GMP requirements and pharmaceutical quality systems.
• Demonstrated experience in batch review, certification and release.
• Strong understanding of deviations, investigations, CAPA, change control and quality risk management.
• Experience supporting regulatory inspections and GMP audits.
• Strong technical judgement and the ability to make independent quality decisions.
• Excellent attention to detail and documentation standards.
• Strong communication and cross-functional collaboration skills.
• Ability to operate effectively within a regulated manufacturing environment.
• Experience within an Irish HPRA-regulated manufacturing environment.
• Experience supporting HPRA or other competent authority inspections.
• Broad experience across pharmaceutical manufacturing, Quality Assurance and batch certification activities.

The Opportunity

This is a full-time permanent opportunity within an established pharmaceutical manufacturing operation in the Munster region. The successful candidate will hold an important quality and compliance position, working closely with site Quality and Manufacturing functions.

This search is being conducted on a confidential basis. All applications and enquiries will be treated in strict confidence.