GMP QA Manufacturing Specialist - Aseptic (Global Team)

Grifols, S.A; Dublin; On-site; EUR 65,000 - 90,000; Full time

Benefits offered by this job

Highly competitive salary

Group pension scheme

Private Medical Insurance

Education allowance

Wellness activities

Job summary

Grifols, S.A. in Ireland is seeking a QA Manufacturing Specialist to provide quality oversight on the shop floor for GMP operations in the Albumin facility.

You will partner with Manufacturing, Maintenance, Automation and Quality teams to ensure safe, compliant production and timely batch release. Required: a bachelor’s in a scientific field and 3+ years in aseptic GMP manufacturing, experience with QMS systems (LIMS/Veeva/Trackwise) and deviation/CAPA processes; strong attention to detail and

Qualifications

• Bachelor’s degree in a scientific discipline.
• 3+ years’ aseptic GMP manufacturing experience.
• Experience with QMS processes (paper/electronic).
• Understanding of Annex 1 and FDA guidance.

Responsibilities

• Provide QA oversight for GMP operations and cGxP compliance.
• Support batch release readiness through timely QA reviews.
• Review and approve GMP documentation and records.
• Assist deviations, investigations and CAPAs, change controls.
• Coach ops teams on quality, asepsis and contamination control.
• Participate in risk assessments and validation activities.
• Maintain inspection-ready documentation and support inspections.

Skills

Aseptic manufacturing

GMP compliance

QMS processes

GEMBA walks

CAPA investigations

Batch records

Risk assessments

Documentation review

Education

Bachelors degree in science

Tools

LIMS

Veeva Vault

Trackwise

Job description

Grifols, S.A. in Ireland is seeking a QA Manufacturing Specialist to provide quality oversight on the shop floor for GMP operations in the Albumin facility.

You will partner with Manufacturing, Maintenance, Automation and Quality teams to ensure safe, compliant production and timely batch release. Required: a bachelor’s in a scientific field and 3+ years in aseptic GMP manufacturing, experience with QMS systems (LIMS/Veeva/Trackwise) and deviation/CAPA processes; strong attention to detail and