23094-QA Specialist – Cork Contractor

QA Specialist

Purpose

The Quality Specialist will provide Quality oversight, support and expertise to GMP related activities.

Responsibilities

• Review and approve production and analytical documentation accompanying the release of drug substance, drug product 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 CAPA’s.
• Creates and maintains assigned SOPs.
• Compile data for reports and presentations, provides data interpretation draws conclusions.
• Completes audits to ensure compliance to 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. Utilise 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.
• 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.

Qualifications

• At least 5 years’ experience in the Pharmaceutical, Biopharmaceuticals industry or a similar operating environment which includes a minimum of 2 years’ experience in a Quality Assurance/Quality Control function.
• Degree in Science, Engineering or similar
• Solid knowledge of cGMP

• Strong understanding of Quality Assurance processes and regulatory frameworks.
• Ability to interpret complex data and provide clear conclusions and recommendations.
• Knowledge of regulatory requirements for batch release, QP certification, and GMP documentation.
• Strong problem-solving skills, with the ability to identify compliance gaps and recommend continuous improvements.
• Excellent written and verbal communication skills.
• Ability to work well in cross-functional teams and collaborate effectively across departments.