Spclst, Quality Assurance

MSD; Ireland; Hybrid; EUR 50,000 - 70,000; Full time

Job summary

MSD Ballydine facility is seeking a Quality Specialist to support day-to-day QA activities on site and act as a core member of the Process IPT. You will review batch records, support CAPA investigations and drive continuous improvement across quality systems.

The role requires a degree in Science or Pharmacy, knowledge of GMP and IT systems such as SAP or TrackWise, and experience with lean methodologies. The position offers hybrid working arrangements and a pathway to robust career development.

Qualifications

• Degree or post-graduate qualification in Science, Pharmacy or equivalent.
• Knowledge of Quality IT systems desirable (e.g. SAP, Trackwise).
• Lean / Continuous Improvement methodology knowledge.
• GMP requirements for electronic/paper-free operations.

Responsibilities

• Participate as functional expert in cross-functional team that manages production right first time on site.
• Review and approve batch, cleaning and testing documentation.
• Investigate, document and drive CAPA for deviations and OOS; support deviation investigations and process performance monitoring.
• Lead or assist in audits and GMP walkthroughs; communicate quality metrics.

Skills

Quality systems

Lean / Continuous Improvement

GMP knowledge

Communication

Cross-functional teamwork

Education

Science/Pharmacy degree or equivalent

Tools

SAP

TrackWise

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:

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 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:

• 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.

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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

Job Posting End Date: 10/30/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.