QA Lead - Bulk Drug Substances (GMP)

AstraZeneca; Athlone; On-site; EUR 70,000 - 90,000; Full time

Job summary

AstraZeneca plc Athlone site seeks a QA Specialist for the Bulk Drug Substance facility to ensure products are manufactured in compliance with cGMP and regulatory requirements. You will oversee QA activities across manufacturing, testing, labeling and storage of Bulk Drug Substances, aligning with the AAMF QMS and global quality standards.

You will collaborate with Operations, QC, Technical Services and Engineering to support patient supply, inspection readiness, deviation and CAPA management,

Qualifications

• B.Sc. in Science/Engineering with ≥3 years in cGMP quality.
• Minimum 3 years QA pharma industry experience.
• Strong knowledge of cGMP requirements.
• Experience with GMP management and regulatory authorities.
• Excellent attention to detail.
• Knowledge of TrackWise or similar.
• Strong communication and multitasking abilities.

Responsibilities

• Provide quality and cGMP input and oversight for all manufacturing activities for the Bulk Drug Substance facility.
• Review and approval of technical support documentation (cleaning, process, method validation).
• Review and approval of SOPs, Work Instructions, technical reports and protocols.
• Participate in quality risk assessments and maintain quality oversight.
• Review and approve Validation protocols as required.
• Support inspection readiness and responses to inspection observations.
• Review and approve Master Batch Records and GMP-related procedures.
• Oversee CAPA, Deviation, Change Control and Preventive Maintenance in QA.

Skills

Quality Assurance

cGMP

Documentation control

Regulatory knowledge

Communication

Planning & organizing

Audit experience

Education

B.Sc. in Science/Engineering

Tools

TrackWise

MS Office

Job description

AstraZeneca plc Athlone site seeks a QA Specialist for the Bulk Drug Substance facility to ensure products are manufactured in compliance with cGMP and regulatory requirements. You will oversee QA activities across manufacturing, testing, labeling and storage of Bulk Drug Substances, aligning with the AAMF QMS and global quality standards.

You will collaborate with Operations, QC, Technical Services and Engineering to support patient supply, inspection readiness, deviation and CAPA management,