JOB DESCRIPTION

Department: Development Quality

Title: QC Specialist 

Purpose The Specialist is a member Of a team within Quality and is involved in supporting the GMP Quality Assurance activities at the site.

Key Result Areas and Primary Activities

• 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.
• Compiles 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
• 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

Skills Required

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

Our Vision: To be recognised as the best STEM Contracting & Permanent Recruitment company and the Employer of Choice for top performing Recruiters.

For further information on this role please contact Geraldine Gormally on 0861071395  / recruit@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/  

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