Aine Corrigan Email & Phone Number

• Quality oversight of Contract Manufacturing Organizations (CMOs) for Hospital and Internal Medicine to ensure that the products supplied are manufactured and tested in accordance with c-GMPs, the registration file and.
• Expertise in sterile injectables, lyophilised powders, fast melt tablets, solid dose, liquid dose, granules and suppositories. Drug substance and drug product.
• Effective management of quality issues and corrective action plan and make decisions that may involve complex quality and technical issues.
• Highly independent position operating with minimal supervision, interacting with high levels of management both at contract manufacturers and within Pfizer.
• Operate as spokesperson for department and spend a significant period developing relationships, independently negotiating, developing and communicating Pfizer quality requirements with contract manufacturers. Strong.
• Ensure appropriate internal networking to develop and maintain close and effective business partner relationship with internal colleagues.

Grange Castle, Dublin

• Develop and maintain innovative cleaning validation strategies. Drive execution of all aspects of cleaning validation studies in a drug substance manufacturing site.
• Participate in external audits and audit other areas onsite.
• Identify and drive continuous improvements within the group to ensure streamlined and efficient Cleaning Validation for new product introduction.
• Manage projects, prepare status reports and present out to other departments.
• Provide support and guidance to other team members.
• Provide expertise for trouble shooting and resolution of analytical or technical issues which may occur

Newry, Northern Ireland

• Cleaning Validation Analyst
• Initial and annual validation of cleaning procedures in 25 multi-product manufacturing suites (sterile and non-sterile).
• Schedule and execute all cleaning validation runs; Perform sampling, testing, analysis of results, troubleshooting, interpreting and reporting of results.
• Analytical method development, validation and optimisation.
• Generate validation protocols, reports, method of analysis, SOPs, validation master plans and acceptance criteria.
• Defend cleaning validation strategies in audits Process Validation Analyst

Ballivor, Co.Meath

Higher National Diploma, Leadership Development, First Class Honors (1:1)

Leadership, team effectiveness, group dynamics, talent management, innovation problem solving

Bachelor Of Science (B.Sc.) Honours In Biopharmaceutical Science, First Class Honours (1.1)

Bachelor Of Applied Science (B.Sc.), Merit Grade 1 (2.1)

Leaving Certificate