Associate Specialist, Quality Assurance

MSD Ireland; Ireland; Hybrid; EUR 34,000 - 48,000; Part time

Job summary

MSD Ireland is seeking a Part Time Associate Quality Specialist (8 hours per week) to join our quality team. You will act as a functional quality expert within cross-functional groups, supporting RFT performance, deviations investigations, CAPA, and QA oversight for analytical and microbiology labs.

The role covers root cause analysis, quality systems, and documentation governance, with a focus on continuous improvement and regulatory compliance in a hybrid work arrangement.

Qualifications

• Degree or post-graduate qualification in Science, Pharmacy or equivalent.
• Knowledge of Quality IT systems desirable (e.g. SAP, TrackWise, Document Management Systems).
• Knowledge and demonstrated expertise in Lean / Continuous Improvement.
• Experience and knowledge of GMP Requirements for Electronic /paper free operations.
• Excellent written and oral communication skills.

Responsibilities

• Participate as a quality expert in cross-functional team to manage site RFT performance.
• Support deviation investigations and OOS/OOT investigations; perform technical trending.
• Ensure robust root cause analysis and effective CAPA.
• Provide QA support for site chemistry and microbiology labs; review method validation and transfer protocols.
• Evaluate material stability data and support expiry extensions.
• Prepare Annual Process, System and Product Reviews.
• Coordinate and maintain Quality and Change Agreements registers.
• Participate in internal GMP audits and walkdowns.
• Contribute to generation and communication of site quality metrics.
• Create, review and approve quality procedures; drive continuous improvement.

Skills

Quality IT systems

Lean / CI

GMP knowledge

Communication skills

Team work

Decision making

Adaptability

Attention to detail

Problem solving

Education

Science/Pharmacy degree

Tools

SAP

TrackWise

Document Management Systems

Job description

Job Description

An amazing opportunity has arisen for a Part Time Associate Quality Specialist. This is an 8 hour per week position. Bring energy, knowledge, innovation and leadership to carry out the following:

What You Will Do

• Right-First-Time Performance: Participate as a functional quality expert in the cross-functional team that manages site production Right-First-Time (RFT) performance.
• Deviation & OOS Oversight: Provide support to deviation investigations and Laboratory Out of Specification (OOS) / Out of Trend (OOT) investigations. Perform technical trending on deviations to identify improvement initiatives.
• Root Cause & CAPA: Apply detailed knowledge of quality systems to ensure that robust root cause analysis is performed and effective Corrective and Preventive Actions (CAPA) are completed.
• Analytical & Microbiology QA Support: Provide QA compliance support for site chemistry and microbiology laboratories. Review and approve analytical/microbiological method validation, verification, and transfer protocols and reports (e.g., HPLC, bioburden, endotoxin testing) in line with regulatory guidelines.
• Material Expiry Evaluation: Evaluate raw material, intermediate, and API stability data to technically support and justify shelf-life/expiry extensions and retest date evaluations.
• Annual Reviews: Prepare Annual Process, System, and Product Reviews.
• Quality & Change Agreements: Coordinate and maintain the site's Quality Agreements (QAs) and Change Agreements (CAs) registers, authoring or revising active agreements as required.
• Internal Audit Programme: Active participation in the site internal audit programme, including scheduled GMP audits and routine internal walkdowns, to drive site compliance and inspection readiness.
• Quality Metrics: Contribute to the generation, analysis, and communication of site quality metrics for site Quality Councils and leadership.
• Documentation & Governance: Create, review, and approve standard quality procedures as required.
• Continuous Improvement: Provide feedback on recurring issues to ensure continuous improvement of site systems and processes.

What Skills You Will Need

• Degree or post-graduate qualification in Science, Pharmacy or equivalent.
• Knowledge of Quality IT systems desirable (e.g. SAP, Trackwise, Document Management Systems).
• Knowledge and demonstrated expertise in Lean / Continuous Improvement.
• Experience and knowledge of GMP Requirements for Electronic /paper free operations.
• Communications: Excellent written and oral communication skills. Organizes and delivers information appropriately.
• Team Work: Interacts with people effectively. Able and willing to share and receive information.
• Decision Making: Uses sound judgement to make good decisions based on information gathered and analysed.
• Adaptability: Adapts to changing work environments, work priorities, organizational needs and diverse people.
• Work Standard: Sets and maintains high performance standards. Pays close attention to detail, accuracy and completeness.
• Motivation: Displays energy and enthusiasm. Maintains high level of productivity and self direction.

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.

So, If You Are Ready To

Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology.

Required Skills

Analytical Problem Solving, Analytical Problem Solving, Aseptic Filling, Audit Processes, CAPA Management, cGMP Compliance, Complaint Management, Compliance Activities, Corrective Action Management, Decision Making, Deviation Management, Document Management, Evaluate Information, Good Manufacturing Practices (GMP), Information Assurance Management, Productivity Management, Quality Assurance Processes, Quality Assurance Systems, Quality Auditing, Quality Management Standards, Quality Management Systems (QMS), Quality Metrics, Quality Standards, Quality Support, Root Cause Analysis (RCA) {+ 7 more}

Employee Status

Regular

Flexible Work Arrangements

Hybrid