QA Specialist

Berkley Group; Carlow; Hybrid; EUR 45,000 - 67,000; Full time

Job summary

Berkley Group in Carlow is seeking a Quality Assurance Specialist to join a pharmaceutical manufacturing team on an initial 11-month contract. The role is hybrid, with 1-3 days on site.

You will review documentation for new product introductions, manage supplier quality agreements, monitor supplier performance, and support deviations, CAPAs, change controls and complaints. A science degree and 3-5 years QA experience preferred.

Qualifications

• 3-5 years in a quality role, ideally in pharmaceutical manufacturing.
• Working knowledge of cGMP and GDP.
• Experience with equipment and process validation.
• Familiarity with sterile filling processes.
• A degree in a science discipline.

Responsibilities

• Supplier management oversight and Quality Agreement management
• Review documentation for new product and material introduction
• Develop and monitor supplier performance metrics
• Support deviations, CAPAs, change controls and supplier complaints
• Author, review and approve protocols and reports for technology transfer and method validation

Skills

Quality assurance

cGMP knowledge

Process validation

Sterile filling

Education

Science degree

Job description

Quality Assurance Specialist, Carlow, 11-month contract

A pharmaceutical manufacturing company in Carlow is looking for a Quality Assurance Specialist to join their team on an initial 11-month contract. Hybrid role, 1-3 days per week onsite. Start date: ASAP.

The role:

• Supplier management oversight and Quality Agreement management
• Review documentation for new product and material introduction
• Develop and monitor supplier performance metrics
• Support deviations, CAPAs, change controls and supplier complaints
• Author, review and approve protocols and reports for technology transfer and method validation

What you need:

• 3-5 years in a quality role, ideally in pharmaceutical manufacturing
• Working knowledge of cGMP and GDP
• Experience with equipment and process validation
• Familiarity with sterile filling processes
• A degree in a science discipline

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