QA Validation Engineer

We are currently recruiting an ambitious and experienced QA Validation Engineer for our clients Biologics / Fill Finish site in Sligo.
 
Why you should apply:

• Our client has developed a culture of innovation, inclusion, and development, and consistently features as a great place to work.


• The role is generously compensated and attracts a competitive base salary and highly attractive benefits package.

 
What you will bedoing:

• Coordinate / direct and actively participate in the validation and quality assurance of site equipment, utilities, processes and software in compliance with company policies, FDA, European cGMP and GAMP standards.


• Generate/maintain/execute the Site Validation Master Plan and Project Validation Plans and schedules.


• Generate validation protocols and final reports to cGMP standards.


• Generate validation investigations and implementation of corrective actions.


• Create/Review/Approve various quality documents and test data.


• Manage validation, exception event, and change control processes.


• Maintain and track validation equipment, if applicable.


• Update validation procedures, job instructions and batch documentation to reflect current best practices.


• Perform cross training within the team and training of new team members.


• Maintain the overall cGMP compliance of the production areas.

 
What you need to apply:

• 3rd level degree in engineering or scientific discipline.


• A minimum of 3 years validation/Quality experience in pharma/biopharma operations (Facilities, Utilities and Equipment). 


• A minimum of 3 years of knowledge of cGMP and regulatory requirements relating to the pharma/biopharma industry.    


• Ability to work well both independently and in a team environment.