Head of Quality

HEAD OF QUALITY| TALLAGHT| PHARMACEUTICAL

I am working on an exclusive partnership with my client on their very exciting Head of Quality vacancy.

The Head of Quality will oversee the activity of the quality assurance and quality control staff through developing, implementing, and maintaining a system of quality and reliable testing for the Company's products and/or development processes. The Head of Quality is also responsible for site regulatory compliance and for compliance of systems/procedures to all relevant GMP/GDP requirements. This individual will also support, where required any Qualified Person responsible for the timely and compliant release of products to the market.

Head of Quality Responsibilities:

• Ensure all in-house quality procedures, standards and specifications are compliant with current cGxP.

• Ensuring the quality management system is operating as efficiently and effectively as possible and is compliant with HPRA requirements.

• Assessing CMO customer requirements and ensuring that these are met.

• Determining raw material and finished goods testing timelines to share with production department to enable compilation of purchasing and production schedule.

• Responsible for tech transfers of products onto Tallaght site.

• Responsible for developing and integrating test methods to allow EU release of product manufactured in the UK.

• Responsible for validation of any new equipment or processes brought into the plant.

• Review of current manufacturing processes and methods to ensure optimal batch sizes are being produced and where not, advise necessary changes required from quality perspective to facilitate a change.

• Responsible for the overall quality budget.

• Specifying quality requirements of raw materials with suppliers.

• Managing all QA and QC staff, setting objectives and rostering weekly activities to facilitate production schedule.

• Encouraging and managing change and improvement in performance and quality.

• Recording, analysing and distributing statistical information to enable performance management.

• Trouble shooting, problem solving and achieving practical solutions to any issues which arise in QA or QC.

• Carrying out and monitoring testing and inspection of products and materials to ensure the finished product meets quality standards.

Head of Quality Requirements:

• A 3rd level qualification in a relevant science or Quality discipline.

• 3-4 years working as a Quality Manager with previous pharmaceutical industry experience.

• Proficient in validating production and laboratory equipment, generating validation documents independently, and providing technical quality support.

• Familiar with temperature mapping, risk assessments, HVAC function, HEPA filter testing, supplier management, and artwork template management, demonstrating strong organizational and project management skills.

• Experience managing a transition of a QMS from paper to electronic very beneficial.

• Strong supervisory and leadership skills.

For a confidential discussion, please contact Tina Cornally.

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