Spclst, Quality Assurance

MSD; Ballydine; Hybrid; EUR 60,000 - 85,000; Full time

Benefits offered by this job

Hybrid work

Job summary

MSD in Ballydine, Ireland, is seeking a Quality Specialist to support day-to-day QA activities on site as a core member of the Process IPT. You will review batch, cleaning and testing documentation and ensure OOSs and deviations are documented with CAPAs.

The role involves deviation investigations, quality systems guidance, risk assessments, change controls, and annual reviews, with hybrid work and an equal opportunity ethos.

Qualifications

• Degree or post-graduate qualification in Science, Pharmacy or equivalent.
• Knowledge of Quality IT systems such as SAP and Trackwise.
• Spray drying experience desirable.
• Knowledge and expertise in Lean / Continuous Improvement.
• GMP requirements for electronic/paper-free operations.
• Experience in High potency manufacturing desirable.
• Excellent written and oral communication; able to share and receive information.
• Teamwork, adaptable, and able to maintain high standards.

Responsibilities

• Participate as functional expert in the cross functional team that manages production right first time at site.
• Review and approve batch, cleaning and testing documentation.
• Ensure that all Laboratory Out of Specification (OOS) and process deviations are documented, assessed and associated CAPA identified.
• Provide support to deviation investigations and process performance monitoring; perform trending on deviations to identify improvements.
• Provide knowledge of quality systems and ensure root cause is identified with corrective actions completed.
• Provide guidance on quality requirements to maintain validation status, including participation in risk assessments.
• Provide feedback on recurring issues to ensure continuous improvement.
• Ensure change controls are documented, assessed and completed.
• Prepare Annual Process and System Reviews.
• Lead audits to support GMP walkdowns and scheduled audits.
• Generate and communicate quality metrics.
• Create, review and approve quality procedures.

Skills

Quality IT systems

Lean CI

GMP knowledge

High potency

Communication skills

Teamwork

Decision making

Adaptability

Education

Degree in Science or Pharmacy

Tools

SAP

Trackwise

Job description

Job Description

A fantastic opportunity has arisen for a Quality Specialist.

Quality Specialist supports day to day QA activities on site. The Quality Specialist participates as a core member of the Process IPT (Integrated Process Team).

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

• Participate as functional expert in the cross functional team that manages production right first time at site.
• Review and approve batch, cleaning and testing documentation.
• Ensure that all Laboratory Out of Specification (OOS) and process deviations are documented, assessed and associated CAPA identified.
• Provide support to deviation investigations and process performance monitoring. Perform trending on deviations raised as required to identify improvement initiatives.
• Provide detailed knowledge of quality systems in place and ensure that root cause is identified and corrective actions as appropriate are completed.
• Provide guidance on quality requirements to maintain validation status, including participation in process/product Risk Assessments.
• Provide feedback on re-occurring issues ensuring continuous improvement to systems/processes.
• Ensure changes controls raised are documented, assessed and completed.
• Prepare Annual Process and System Reviews.
• Act as lead/team auditor to support the internal GMP walkdown and scheduled audits.
• Participate in the generation and communication of quality metrics.
• Creation, review and approval of quality procedures as required.

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).

• Spray drying experience desirable.

• Knowledge and demonstrated expertise in Lean / Continuous Improvement.

• Experience and knowledge of GMP Requirements for Electronic /paper free operations.

• Experience in High potency manufacturing desirable.

• 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.

First established in 1976, our Ballydine facility develops and supplies the active ingredients and final formulated product for a range of innovative medicines at its manufacturing and R&D facilities. Ballydine was our Company's first site in Ireland, the Ballydine site is our Company's primary small molecule pipeline commercialisation facility globally, operating as a European hub for quality, manufacturing, and engineering. Its highly skilled teams lead the way in the development of new medicines, including innovative treatments for Hepatitis C, HIV and immuno-oncology, the site exports to over 25 countries around the world.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

Required Skills:

Aseptic Manufacturing, Aseptic Manufacturing, Audits Compliance, CAPA Management, Change Controls, Controls Management, Corrective Action Management, Corrective and Preventive Action (CAPA), Detail-Oriented, Documentation Review, Driving Continuous Improvement, GMP Compliance, Manufacturing, Operational Quality, Process Improvements, Process Verification, Quality Assurance Processes, Quality Assurance Systems, Quality Assurance Tools, Quality Auditing, Quality Compliance, Quality Control Systems, Quality Management Systems (QMS), Quality Measurements, Quality Metrics {+ 8 more}

Employee Status:

Regular

Flexible Work Arrangements:

Hybrid

Job Posting End Date:

10/30/2026

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.