Spclst, Quality Assurance

Merck; Ireland; On-site; EUR 65,000 - 90,000; Full time

Job summary

Merck Ballydine, Ireland, seeks a Quality Specialist to support day‑to‑day QA activities on site and drive continuous improvement within the Process IPT. You will review batch and testing docs, manage deviations, CAPAs, and participate in audits while applying GMP standards across the facility.

Ideal candidates hold a science or pharmacy degree with experience in GMP, quality systems, and IT tools such as SAP and Trackwise; strong communication and teamwork are essential.

Qualifications

• Degree or post-graduate qualification in Science, Pharmacy or equivalent.
• Knowledge of Quality IT systems desirable (e.g. SAP, Trackwise).
• Experience in GMP environments and deviation investigation is preferred.
• Familiarity with CAPA management and change controls is advantageous.

Responsibilities

• Participate as functional expert in cross-functional team that manages production right first time at site.
• Review and approve batch, cleaning and testing documentation.
• Ensure all OOS and process deviations are documented and CAPA identified.
• Provide support to deviation investigations and process performance monitoring.
• Lead quality system reviews and participate in audits; communicate quality metrics.

Skills

Aseptic Manufacturing

Audits Compliance

CAPA Management

Change Controls

GMP Compliance

Process Improvements

Quality Assurance Tools

Quality Auditing

Quality Management Systems

Education

Degree in Science or Pharmacy

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:

• 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.

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}

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.

Employee Status: Regular

Relocation: