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QA Team Lead & QP

Reference:APDE-358262 Location: Galway
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed

QA Team Lead & QP
Our client, a global pharmaceutical organisation are currently recruiting for a QA Team Lead to join their team on a permanent basis. The suitable candidate will also be an experienced QP.

• Manage the day to day administration of all required Quality Management System elements assigned in line with the appropriate current Quality policies/procedures and appropriate quality regulations
• Perform QA/QP batch release as required to support operational business requirements (the job holder is required to be named on the site manufacturing licence as a QP and perform QP batch release as per current relevant EU guidelines)
• Provide direct leadership, mentoring and guidance to all relevant Quality Assurance staff to ensure excellent performance while maintaining a positive team environment
• Provide QA input into relevant Risk Management programmes within the company and to utilise risk management tools to support science based decision making is support of the highest product quality, safety and efficacy standards
• Develop and implement effective performance monitoring indicators for the Quality Assurance department
• Actively participate in Material review boards, Product quality reviews, Site Quality Council and Quality management reviews
• Operate alongside operational teams in the timely resolution of batch investigations, change management and in the implementation of operational excellence initiatives
• Ensure Quality oversight and input to new product and process introduction on site
• Identify and lead continuous improvement projects for the site as required

• Minimum of a Bachelor's degree (or equivalent) in a Science related discipline and 8+ years’ relevant experience within a pharmaceutical company with a minimum of 3 years’ experience within a Quality Assurance role. Previous experience in a sterile product manufacturing facility is highly desirable
• Be registered as a Qualified Person on the company licenses (Previous experience with release of sterile products desirable)
• Must possess knowledge and experience of all quality system aspects including: Deviation management, CAPA, Complaint handling, auditing, change management, supplier qualification, and batch release
• Knowledge of Trackwise Quality management system, Quality Control testing, Validation and Aseptic manufacturing an advantage but not essential
• Proficiency in speaking, comprehending, reading and writing English is required

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

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