Overview
Quality Assurance Analyst Jobs in County Carlow, Ireland at Independent Solutions
Title: Quality Assurance Analyst
Company: Independent Solutions
Location: County Carlow, Ireland
Quality Assurance Specialist – Carlow
Mode- Fully Onsite- Contract Shift role
Job Overview
We are seeking a Quality Assurance Analyst to provide quality support to production teams within a pharmaceutical manufacturing environment. The role will focus on maintaining cGMP compliance, supporting batch release activities, reviewing manufacturing documentation and responding to quality and operational issues in a dynamic production environment.
Previous experience working shifts, particularly within a Quality or aseptic manufacturing environment, is beneficial.
This is a 4-cycle, 12-hour shift position.
Key Responsibilities
- Provide Quality Assurance support to production teams to ensure compliance with cGMP and internal quality standards.
- Review batch documentation, electronic batch records (EBRs), line clearances, investigations and quality reports in a timely manner.
- Identify, assess and support resolution of quality concerns based on risk.
- Respond promptly to unplanned events, deviations and technical issues within the manufacturing environment.
- Support production line spot checks and GMP walk-throughs to maintain ongoing audit readiness.
- Monitor and report Quality Right First Time and audit-readiness metrics.
- Support continuous improvement initiatives and promote strong GMP and quality standards across manufacturing operations.
- Participate in customer complaint investigations where required.
- Work closely with Production, Quality, Engineering and other cross-functional teams.
- Maintain compliance with applicable Quality, Manufacturing and EHS management systems.
- Use electronic systems and databases to complete daily quality activities and maintain accurate documentation.
Quality Systems & Technical Requirements
Experience or working knowledge of the following is desirable:
- SAP
- MES
- TrackWise
- Electronic Batch Records
- Batch documentation systems
- Quality Management Systems
- Regulatory & Compliance Requirements
- Strong knowledge of cGMP requirements.
- Understanding of Irish, European and international pharmaceutical regulatory requirements and standards.
- Knowledge of GDP principles.
- Ability to interpret and apply quality procedures, standards and policies.
- Strong documentation and report-writing skills.
- Commitment to data integrity, compliance and audit readiness.
Qualifications & Experience
- Bachelor’s Degree or higher in a Science or related discipline preferred.
- 2-3 years’ experience in a Quality Assurance/Quality role within pharmaceutical manufacturing.
- Experience within an aseptic or sterile manufacturing environment is highly desirable.
- Previous experience working in a manufacturing quality function or on production floors is beneficial.
- Experience with SAP, MES and TrackWise is desirable.
- Strong organisational skills with the ability to manage multiple priorities and meet deadlines.
- Ability to work independently while contributing effectively within a cross-functional team.
- Strong communication, problem-solving and decision-making skills.
