Quality Specialist

CareerWise Recruitment; Waterford; Hybrid; EUR 46,000 - 59,000; Full time

Job summary

CareerWise Recruitment is seeking aQuality Specialist for a 12-month contract in Waterford. The role is on-site 3 days and home 2 days, with GMP QA responsibilities across procedures, batch documentation, and quality systems.

You will join the QA team to ensure cGMP compliance, develop GMP training, review documentation, conduct audits, and drive continuous improvement initiatives within a pharma client.

Qualifications

• Minimum 2–5 years’ experience in a similar QA role.
• Experience in a GMP environment is required.
• Third level qualification in science or related discipline preferred.

Responsibilities

• Work as part of the QA team on site ensuring products meet cGMP.
• Develop and deliver GMP training packages.
• Prepare and review procedures and batch documentation.
• Perform audits of all departments to schedule.
• Ensure quality systems are implemented and maintained.
• Act as Quality point of contact for systems/processes.
• Review documentation/investigations/reports to resolve concerns.
• Close quality actions/findings with relevant departments.
• Contribute to continuous improvement initiatives.
• Measure and report RFT/trend data and resolve recurring issues.
• Participate in supplier and regulatory audits and quality initiatives.
• Review procedures and practices critically.
• Support investigations of deviations and ensure release readiness.
• Ensure cGMP compliance at all times.

Skills

Quality Assurance

GMP experience

Audit experience

Training delivery

Education

B.Sc. in science or related discipline

Job description

A Quality Specialist is required by CareerWise Recruitment for a 12-month contract position with our Waterford based pharmaceutical client. You would have to be 3 days working on site and 2 days working from home. You If you have quality assurance experience in a GMP environment working on procedures , batch documentation, maintaining quality systems and worked on delivery of training of these Quality systems then this is the position for you.

THE ROLE

• Working as part of the Quality Assurance team on site ensuring products are manufactured, stored and packaged in accordance with cGMP
• Support the development of GMP training packages and delivery of training
• Participate in the preparation and review of procedures and batch documentation
• Perform audits of all departments to agreed schedule
• Ensure that the quality systems is effectively implemented and maintained
• Acts as Quality Point person for systems / processes providing guidance / feedback on quality issues
• Perform timely review of documentation / investigations /reports highlighting and assisting in the resolution of concerns commensurate with the risk
• Work with relevant departments to ensure timely closure of quality actions / findings
• Actively contribute to continuous improvement initiatives
• Measure and report RFT / trend data and work with departments to resolve recurring issues
• Participate in internal supplier and regulatory audits and key quality initiatives as appropriate
• Perform critical/ constructive review of procedures and practices
• Support investigation of deviations ensuring all product deviations are closed prior to product release
• Ensure compliance to cGMP at all times

REQUIREMENTS

• Third Level qualification (degree in science or related discipline preferred).
• Minimum of 2 - 5 years’ experience in a similar role
• Experience working in a GMP environment is required