Senior Quality Assurance Officer

Baker Finn Recruitment; Waterford; On-site; EUR 45,000 - 65,000; Full time

Job summary

Baker Finn Recruitment client seeks a QA Officer to support GDP activities, quality management systems and regulatory surveillance across Irish and global quality operations. You will help maintain compliance and drive continuous improvement in GMP environments.

The role involves supporting the GDP RP, preparing risk assessments, handling deviations and CAPA, and generating quality metrics. A BSc and 2+ years’ GMP experience are preferred.

Qualifications

• BSc in a science-related discipline; pharma focus is advantageous.
• At least 2 years’ experience in GMP pharmaceutical QA.

Responsibilities

• Support GDP RP activities, including meetings and follow-ups.
• Prepare shipping risk assessments and verification protocols.
• Record and close EU/UK/RO distribution complaints and temperature excursions.
• Act as Deputy Responsible Person for client products.
• Prepare Ireland quality metrics and RP oversight reports.
• Identify trends and opportunities for improvement.
• Lead eQMS regulatory surveillance improvements with Global Quality Team.
• Develop binder management in the Dot Compliance eQMS and verify checks.
• Progress deviations, CAPA, change controls, risk assessments and audits.
• Review artwork changes with Operations.

Skills

GMP experience

QA oversight

Regulatory awareness

Data trending

Education

BSc in science-related discipline

Tools

eQMS platforms

MS Office

SharePoint

Job description

Our client is seeking a QA Officer to support Good Distribution Practice (GDP) activities, quality management systems, regulatory surveillance and continuous improvement across Irish and global quality operations.

GDP Support

• Support the GDP Responsible Person (RP), including customer oversight meetings, minutes and follow-up actions.
• Prepare and execute shipping risk assessments and shipping verification protocols.
• Record, investigate and close EU, UK and rest-of-world distribution complaints and shipment temperature excursions.
• Act as Deputy Responsible Person for the client’s products.

Quality Metrics & Trending

• Prepare monthly and quarterly Ireland quality metrics, monthly RP oversight reports and local Quality Management Reviews (QMR).
• Identify trends, emerging issues and opportunities for continuous improvement.
• Support the preparation of monthly and quarterly US/global quality metrics and QMR reports.

Regulatory Surveillance & eQMS

• Lead improvements to an electronic regulatory surveillance process aligned with global cGMP requirements, working with the Global Quality Team.
• Conduct quarterly global regulatory surveillance and assess potential impacts on the Quality Management System.
• Develop the binder management process within the Dot Compliance eQMS and carry out routine verification checks.

General Quality Responsibilities

• Progress and approve, as appropriate, deviations, CAPA, change controls, risk assessments, effectiveness checks, shipping validations, SOPs and internal/external audits.
• Support Operations with the review and approval of artwork changes.
• Assist the Global Quality Team with additional quality activities as required.
• Promote a strong quality culture and participate in personal and cross-functional training.
• Support or lead ad hoc project development activities.

Qualifications & Experience

• BSc in a science-related discipline; a pharmaceutical specialism is advantageous.
• At least 2 years’ experience in the pharmaceutical industry within a GMP environment, including routine QA and quality systems activities.

Skills & Knowledge

Technical & Functional

• Strong knowledge of GMP and working knowledge of global pharmaceutical regulations, including FDA 21 CFR Parts 210/211, EU GMP Annexes and PIC/S guidelines.
• Understanding of data integrity principles (ALCOA++), QMS requirements and ICH Q10.
• Experience writing deviation, CAPA and change control reports; risk assessment skills and familiarity with ICH Q9.
• Competence using eQMS platforms and knowledge of EU GMP Annex 11 and 21 CFR Part 11.
• Strong Microsoft Office skills, including Word, Excel, Visio, PowerPoint, Project and SharePoint, for reporting, trending, process flows and presentations.

Analytical & Interpersonal

• Data trending, root cause analysis, problem-solving and issue resolution.
• Strong attention to detail, accuracy, critical thinking and decision-making.
• Effective communication across global teams, stakeholder engagement, adaptability and a proactive approach.