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QA Officer Biologics

Location: Dublin
Experience:2-3 Years
Job Type:Permanent
Salary:Not Disclosed
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May be suitable for: QA Analyst, QA Specialist

QA Officer Biologics
Our client, a global healthcare organisation, requires a QA Officer to join their team on a permanent basis. This is an excellent opportunity to work within the growing biologics space in Ireland.

• Actively support the development and implementation of the Quality Management System
• Develop and maintain local Quality Systems, including standard operating procedures, change control, investigations, corrective and preventative actions, internal auditing, vendor qualification & management, GxP documentation management, batch disposition, complaints and annual product review for commercial and/or clinical operations as appropriate
• Author and review SOPs and Technical Agreements in accordance with procedure, and review Third party GxP documentation in support of Quality Systems and batch disposition
• Support operation of the Training system, including preparing and presenting relevant training material, as required, and manage the GMP Training program and deliver GMP Induction & Refresher training
• Ensure compliance with appropriate regulatory guidance documents, while driving improvements in product and process quality
• Maintain the Manufacturing License and revise when required, and manage Third Party key performance indicators
• Support the implementation of the Operational Excellence program through improvement initiatives
• Comply with company and Legislative Environment, Health and Safety Requirements
• Provide QA oversight of contracted Clinical Research Organisations including, Product Specification File generation and maintenance, review of clinical label packs, and support and execute any other duties as assigned.

• 3rd level qualification in science related discipline
• Minimum 3 years’ experience within a Pharmaceutical QA role
• Relevant experience in GMP/GCP environment - Biologics, Sterile, Clinical and/or Combination Products an advantage
• Background in Regulatory Affairs an advantage
• Strong organisational skills / ability to prioritize work
• Proven track record as a team player
• High level of proficiency in Microsoft Word/Excel

If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252


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