16664-QA Specialist-Tipperary Contractor

This is an 11-month contract.

Purpose:

The team is the Global Development Quality (GDQ) team which is a group that is involved in supporting the global GMP Quality Assurance activities for the IMP Licence. Using this site license we release all Clinical lots to Clinics in the EU and Rest of World. We currently have a team of Quality Specialists and QPs heading up the team. We work closely with similar teams in London, Switzerland, and US in these activities to maintain the Clinical Supply Chain for the Company.

Responsibilities:

• Complete auditing/ review of batch documentation to ensure compliance with SOPs, GMPs, and applicable regulations.
• Review and approve production and analytical documentation accompanying the release of drug substances, drug product, and packaged finished goods to ensure conformance to appropriate SOPs, GMP, and regulatory requirements, including supporting QP certification.
• Actively communicate and collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities.
• Utilise this network to help resolve comments and issues that arise during audit and review.
• Manage product recalls and stock recoveries as appropriate.
•  Identify compliance gaps and make recommendations for continuous improvement.
• Create and maintain assigned SOPs.
• Perform and review complaints and deviation investigations, change controls and CAPAs.
• Assist in the induction process for new starters and training of other staff.
• Generally follows standard procedures and consults with manager/supervisor to ensure resolution of exceptions.
• Compile data for reports and presentations, provide data interpretation, and draw conclusions.
• Carry out all assignments to the standards of compliance, efficiency, innovation, accuracy, and safety in accordance with Company and regulatory requirements.
• Keeps abreast of cGMP requirements as described in applicable worldwide regulations.
• Represents department on cross-functional teams.
• Assist in the generation, review, and approval of Technical & Quality Agreements.
• Additional activities as assigned by the manager/supervisor.

Minimum Qualifications &Requirements:

• Degree in a Quality, Science, or Engineering discipline and potentially a higher degree and/or significant industrial experience.
• 3years of industrial experience.
• Experience should be in the pharmaceutical/chemical industry or government drug-regulatory agency with a working knowledge of cGMP regulations.
• Effective communications (oral/written) and interpersonal skills are necessary.