Associate Specialist, Quality Assurance

MSD Malaysia; Ballydine; Hybrid; EUR 2,066,000 - 3,857,000; Part time

Job summary

MSD Malaysia seeks a Part Time Associate Quality Specialist for an 8 hour per week role in Ireland. The role focuses on quality assurance activities across deviations, CAPA, method validation oversight, and site quality governance.

The candidate will support RFT performance, join cross-functional teams, and help maintain quality systems and site audits, ensuring regulatory compliance and continuous improvement.

Qualifications

• Degree or post-graduate qualification in Science, Pharmacy or equivalent.
• Knowledge of Quality IT systems desirable (e.g. SAP, Trackwise, Document Management Systems).
• Lean / Continuous Improvement experience and GMP knowledge for Electronic/paper free operations.

Responsibilities

• Participate as a quality expert in cross-functional teams to improve Right-First-Time performance.
• Support deviation investigations and OOS/OOT investigations with root-cause analysis.
• Apply robust CAPA and ensure corrective actions are completed.
• Review and approve analytical/microbiological methods validation, verification and transfer protocols.
• Evaluate material expiry data to justify shelf-life extensions and retest dates.
• Coordinate and maintain Quality Agreements and Change Agreements across the site.

Skills

Analytical problem solving

Aseptic filling

Audit processes

CAPA management

GMP compliance

Education

Degree in Science or Pharmacy

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.

What you will do:

Bring energy, knowledge, innovation and leadership to carry out the following: 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:

In order to excel in this role, you will more than likely have: 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

Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s):

Job Posting End Date:

09/21/2026

Company Information

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.