Hybrid Pharma QA Specialist - Data Integrity

Headcount Solutions Polska Sp. z o.o.; Carlow; Hybrid; EUR 55,000 - 75,000; Full time

Job summary

Headcount Solutions Polska Sp. z o.o. invites applications for a Quality Assurance Specialist to join a leading pharmaceutical multinational. This is a hybrid role with 2–3 days on site in Ireland and close collaboration with a global QA team.

You will support new product introductions, review batch records, ensure ALCOA data integrity, and drive cGMP/GDP compliance in daily activities, coordinating with Manufacturing, Engineering and Quality to ensure timely batch releases.

Qualifications

• Bachelor's degree in Science, Engineering or related technical discipline.
• Experience with Quality Management Systems and regulatory compliance.
• 3–5 years' experience in a regulated pharmaceutical/biotech environment.

Responsibilities

• Provide quality support for new product introductions and product release.
• Review and approve manufacturing batch/material documentation including electronic batch records and master data.
• Ensure processes and procedures are in place and followed for all quality activities.
• Report on and monitor the Quality Management System and generate performance reports.
• Collaborate with QA lead/QP to resolve quality queries.
• Ensure ALCOA data integrity for records and data.
• Drive cGMP/GDP compliance in day-to-day activities.
• Identify and support initiatives to improve compliance and batch release efficiency.

Skills

GMP knowledge

QMS experience

ALCOA data integrity

Cross-functional collaboration

Education

Bachelor's degree in Science/Engineering or related discipline

Job description

Headcount Solutions Polska Sp. z o.o. invites applications for a Quality Assurance Specialist to join a leading pharmaceutical multinational. This is a hybrid role with 2–3 days on site in Ireland and close collaboration with a global QA team.

You will support new product introductions, review batch records, ensure ALCOA data integrity, and drive cGMP/GDP compliance in daily activities, coordinating with Manufacturing, Engineering and Quality to ensure timely batch releases.