QA Representative ( Bio Processing)

Berkley Group; Limerick; On-site; EUR 55,000 - 75,000; Full time

Job summary

Berkley Group, Limerick, seeks a Bio Processing QA Representative to join Manufacturing Quality. You will provide QA support to bioprocessing operations, ensuring compliance with cGMP and global quality standards.

Key duties include reviewing batch records, electronic records, logbooks, and protocols; supporting upstream, downstream, media and buffer preparation; and reviewing deviations, investigations, CAPAs, and change control.

Qualifications

• Bachelor's degree in Science, Biotechnology, Biochemistry, Microbiology, Pharmacy, Engineering, or related discipline.
• 2–5 years GMP experience within pharmaceutical or biotechnology manufacturing.
• Strong understanding of cGMP, FDA, and EMA requirements.

Responsibilities

• Act as the primary QA representative supporting bioprocessing manufacturing operations.
• Review and approve batch records, electronic records, logbooks, and protocols.
• Support upstream, downstream, media and buffer preparation operations.
• Review deviations, investigations, CAPAs, and change control.

Skills

GMP experience

Education

Bachelor's degree in Science, Biotechnology, Biochemistry, Microbiology, Pharmacy, Engineering, or related discipline

Job description

Our Client is seeking a highly motivated and detail-oriented Bio Processing QA Representative to join its Manufacturing Quality in Limerick.

The successful candidate will provide Quality Assurance support to manufacturing operations while ensuring compliance with cGMP regulations and global quality standards.

Key Responsibilities

• Act as the primary QA representative supporting bioprocessing manufacturing operations.
• Review and approve batch records, electronic records, logbooks, and protocols.
• Support upstream, downstream, media and buffer preparation operations.
• Review deviations, investigations, CAPAs, and change control

Qualifications & Experience

• Bachelor's degree in Science, Biotechnology, Biochemistry, Microbiology, Pharmacy, Engineering, or related discipline.
• 2-5 years' GMP experience within pharmaceutical or biotechnology manufacturing.
• Strong understanding of cGMP, FDA, and EMA requirements.