18209-QA Specialist-Tipperary Contractor

This is an 11-month initial contract.

Purpose:

The Specialist is a member of a team within Quality and is involved in supporting the GMP Quality Assurance activities onsite.

Responsibilities:

• Review and approve production and analytical documentation accompanying the release of drug substances, drug products, and packaged finished goods to ensure conformance to appropriate SOPs, GMP, and regulatory requirements, including supporting QP certification.
• Perform and review complaints and deviation investigations, change controls, and CAPAs.
• Creates and maintains assigned SOPs.
• Compiles data for reports and presentations provide data interpretation draws conclusions.
• Completes audits to ensure compliance with SOPs, GMPs, and applicable regulations.
• Support product recalls and stock recoveries as appropriate.
• Actively communicate and collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities. Utilize this network to help resolve comments and issues that arise during audit and review.
• Identify compliance gaps and make recommendations for continuous improvement
• Assists in the induction process for new starters and training of other staff.
• Generally, follows standard procedures and consults with manager/supervisor on exceptions.
• Carries 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.
• Additional activities as assigned by the manager/supervisor

Minimum Qualifications & Requirements:

The Specialist is required to possess a degree in a Science or Engineering discipline plus some industrial experience. Alternatively, they must possess considerable industrial experience.