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 any additional country specific requirements.• 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 negotiation skills.• 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• Work to implement a culture of Right-First Time through partnerships with Operations and other functions on site and provide leadership in the use of OE principle.• Participate in common interest groups, attend cleaning conferences across Ireland and the United States with other pharmaceutical organisations.• Organise, chair and provide cleaning validation expertise for cleaning forum meeting held across all departments onsite.

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• HPLC & UPLC analysis of different formulations (tablets, pastes, injections) • Additional testing; particle size, dissolution, moisture content by Karl Fischer, density, titrations, viscosity, UV and other wet chemistry techniques. • Trouble shooting of data and documenting all analysis under regulatory and cGMP guidelines.• Writing of SOPs, protocols and reports.

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