We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

The purpose of this role is to perform QC assignments for quality systems, processes and controls.

Key Responsibilities:

• Liaise with the Quality/ Business Area Specialists/QC Leads) to resolve quality related queries where required.
• Perform laboratory testing and / or materials inspections to determine specification conformance.
• Perform all required analytical, microbiological and control testing to support the site.
• Maintain an adequate, qualified and compliant laboratory environment to conduct testing while adhering to appropriate PPE and safety requirements.
• Support internal and external audits and inspections, ensuring department compliance/readiness.
• Execute/Review /Support deviation/ CAPA activities, complaints, data integrity, Material Qualification, Validation, Quality Risk Management processes and other documentation including generation, investigation, documentation, implementation, verification closure, effectiveness and supporting trending where required for the Quality department and supporting functions.
• Ensure compliance to regulatory requirements.
• Review of all manufacturing batch/ material documentation including (but not limited to) electronic batch records, real time reports, master data using the Quality (Control) systems where required.
• Review of, SOP's, GMP data and other documents as necessary for the Quality department where required
• Contribute to effective writing/revising/rolling out of accurate operational procedures, training materials and maintenance procedures for various Quality related systems.
• Participate in training programs & provide training to other team members as required.

• Bachelors Degree or higher preferred; ideally in a related Science discipline
• 5+ years experience pharmaceutical/biotech experience
• Experience with quality support to qualification/validation, technical transfers and commercial operations