Job Descriptions

Key responsibilities for this role include:

• Actively support the development and implementation of the Quality Management System at Viatris Dublin Biologics Quality.

• 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 Viatris 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.

The minimum qualifications for this role are:

• 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

Skills

• Organisational Skills
• Team Player
• Proficient with Microsoft Office

Experience

• 3+ years