Qualified Person (QP)

Pale Blue Dot Recruitment; Munster; On-site; EUR 90,000 - 130,000; Full time

Job summary

Pale Blue Dot Recruitment is assisting an established pharmaceutical manufacturer in the Munster region to recruit a Senior Qualified Person (QP) to join the Quality team.

The successful candidate will certify finished product batches, review documentation and ensure compliance with GMP, regulatory requirements and Marketing Authorisations. This is a senior role with strong QA focus and cross-functional collaboration.

Qualifications

• Qualified Person status with the appropriate qualifications for Ireland.
• Experience carrying out QP responsibilities in a GMP-regulated pharmaceutical environment.
• Strong working knowledge of EU GMP requirements and pharmaceutical quality systems.
• Experience in batch review, certification and release.
• Knowledge 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 HPRA-regulated manufacturing environment in Ireland.
• Experience supporting HPRA inspections.
• Broad experience across pharmaceutical manufacturing, QA and batch certification.

Responsibilities

• Perform Qualified Person certification of finished product batches in accordance with regulatory and GMP requirements.
• Review batch manufacturing, packaging, testing and related quality documentation prior to certification.
• Investigate and resolve deviations, OOS results and other quality events impacting batch certification.
• Provide QP input into deviations, CAPAs, change controls and investigations.
• Support the Pharmaceutical Quality System and its ongoing development.
• Provide quality guidance for manufacturing, testing, packaging and release activities.
• Assist regulatory inspections and GMP audits as required.
• Collaborate with Quality Assurance, Quality Control, Manufacturing and other functions to maintain GMP compliance.
• Support continuous improvement of quality systems, procedures and compliance processes.
• Maintain documentation and records relating to batch certification and release.
• Stay current with GMP requirements, regulatory guidance and legislation.

Skills

GMP knowledge

Quality Assurance

Regulatory compliance

Documentation

Cross-functional collaboration

Audits/inspections

Batch release

Job description

Location: Munster Region, Ireland
Contract: Full-time, Permanent

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.