Experience

Allergy Therapeutics

• United Kingdom
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• • Mar 2022 - Present

• • Feb 2017 - Apr 2022

  Mentorship and training of junior staff members.Deputising for Validation Manager as required.Project manager for the purchase, installation, and qualification of new plant equipment / facilities, and leading cross-functional teams to meet project objectives.Continued ownership of CSV related projects across all business functions and sites.Continued involvement in all validation activities across all business functions and sites.Liaison with European offices, to ensure validation compliance with local regulations. Show less

• • 2008 - Feb 2017

  Ownership of CSV related projects across all business functions and sites.Subject matter expert for CSV during regulatory audits.Validation responsibility for capital expenditure equipment (filling machines, inspection machine).Working knowledge of sterilisation and depyrogenation equipment / processes and regulations.Involvement in all validation activities across all business functions.Liaison with relevant business functions to ensure validation activities are completed in a timely manner. Show less

• • 2006 - 2008

  Generation and execution of validation protocols relating to the qualification of the in-house ERP system, and associated custom developed applications.Investigation and documentation of any deviations noted during execution. Completion of remedial actions as required.Enhancement and ownership of the site-wide IT change control process.Generation of application specific Standard Operating Procedures.Training of end-users in application use.