Quality Assurance Specialist – GMP & Investigations

Collins McNicholas Recruitment & HR Services Group; Dublin; On-site; EUR 60,000 - 80,000; Full time

Job summary

Collins McNicholas Recruitment & HR Services Group is assisting a global specialty pharmaceutical company based in Dublin to hire 2 Quality Assurance Specialists. The role supports Manufacturing Operations and maintains the QMS within the facility, including investigations of deviations and out-of-spec events.

The position requires a scientific degree, 2+ years in a cGMP environment, strong communication, and the ability to lead or support cross-functional investigations with a focus on

Qualifications

• Bachelor’s degree or higher in a scientific discipline (Biology, Chemistry, or Engineering).
• Minimum 2 years in a cGMP environment.
• Strong communication and mentoring abilities.
• Ability to adapt to change and work independently.
• Statistical analysis and data interpretation skills.

Responsibilities

• Monitor day to day operations to ensure procedures are followed and identify gaps.
• Review manufacturing records for completeness and compliance before product release.
• Review and approve raw materials, intermediates used in manufacturing.
• Perform and evaluate trending of the QMS to support investigations and continuous improvement.
• Interpret and apply all applicable regulatory requirements.
• Lead or support investigations through cross functional teams.
• Present investigations and provide disposition recommendations to site leadership and QP.
• Improve procedures to align with cGMP and regulatory requirements.
• Review and approve procedures, protocols and reports.
• Lead continuous improvement and site projects in quality/operations.
• Participate in internal/external audits as an SME or audit team member.
• Provide shift support to ensure adequate Manufacturing Operations support.
• Approve GMP impacting changes on site.

Skills

Communication skills

Interpersonal skills

Presentation skills

Independent worker

Education

Bachelor's degree in science

Job description

Collins McNicholas Recruitment & HR Services Group is assisting a global specialty pharmaceutical company based in Dublin to hire 2 Quality Assurance Specialists. The role supports Manufacturing Operations and maintains the QMS within the facility, including investigations of deviations and out-of-spec events.

The position requires a scientific degree, 2+ years in a cGMP environment, strong communication, and the ability to lead or support cross-functional investigations with a focus on