QA Specialist
AMC22135
11 month contract
Hybrid - Carlow

Are you passionate about quality assurance and compliance in the pharmaceutical industry? We are offering an exciting opportunity for a QA Specialist to join our clients team in Carlow.

You will play a critical role in ensuring the safety and reliability of our vaccines and biologics manufacturing processes.

This is the perfect role for someone who has 3-5 years in cGMP environment including at least 2 years in QA. Experience with equipment and process validation a massive bonus.

Key Responsibilities:

• Ensure all manufacturing and support systems comply with cGMP and regulatory standards.
• Collaborate with cross-functional teams on-site and remotely, providing day-to-day support and project-based advice on communications, training, audits, inspections, investigations, and system compliance.
• Maintain the site’s audit and inspection readiness.
• Assist in adhering to both divisional policies and regulatory requirements.
• Act as the site lead for various quality systems (e.g., EDMS, CAPA, Deviations), managing issue resolution and trend analysis.
• Identify and resolve quality issues promptly and effectively.
• Provide expertise in implementing quality reporting improvements and fostering continuous improvement within the Quality Management System (QMS).
• Lead and support quality-related projects, metrics, and communication processes to ensure compliance across departments such as labs, facilities, and validation.

• A Bachelor's degree or higher, ideally in a related science discipline.
• Knowledge of EU/US pharmaceutical regulations.
• 3-5 years of experience in a regulated pharmaceutical/biotechnology environment, with a strong focus on aseptic processing, environmental monitoring, and sterile manufacturing.
• Familiarity with industry best practices for quality and compliance.
• Experience in FDA/EU-regulated settings, especially in GMP manufacturing.
• Proven ability to initiate and drive change, with strong project management and communication skills.
• Experience with equipment and process validation.
• Proficiency in Microsoft Office and job-related applications.
• Lean Six Sigma experience (preferred).
• Strong problem-solving, decision-making, and independent working abilities.