Cover Letter Ignace Vallejo, MS. GCP and GMP QA Manager Certified Quality Auditor GMP; by CFPA. Certified Six Sigma “Black belt”. 525 Neptune Ave, Brooklyn, NY 11224. Apt 22 F Home # 718 946 0556. Mobile # 917 359 3028. ignaciovallejo@optonline.net Good Clinical Practice (GCP). Audits were followed according to our SOPs and ICH GCP regulations and Guidelines. The vendor audits were preformed, as follows: • On October/09 an audit was executed for a company that supplies our CRO Company the UAT studies (user acceptance test). The audit was executed by the CRO which sent to the vendor a questionnaire containing 124 questions as called for in the CRO’s SOP. • The CRO also requested the vendors’ permission to conduct an onsite audit. I conducted the onsite vendor audit by reviewing the Master Control SOPs and chose at random 7 SOPs plus randomly choosing 4 employee training folders. • The audit team then discussed the findings of the audit with the auditee. • 15 days later I submitted the audit report with the observations and findings. • On January/2010, the following audits were conducted: • A vendor in Texas who provides space on the internet to handle our data system. • A second vendor, located in New Jersey who supplies our CRO with the system to maintain our SOPs and training records for every employee. • At the CRO I was responsible to perform audits at our overseas sites for our UAT studies. We were executing studies of a new drug for a major pharmaceutical company. These studies were being performed in 29 countries/ 29 languages. • I had the opportunity to conduct patient profile audits in Russia, Mexico and Japan to assure that each patient was qualified to participate in the study. • A digital Pen was used by each patient. • I trained the CRA in each country in the use of the digital pen. • I conducted both internal and external audits. I conducted Monthly cGMP training for all new Employees in the plant regardless of their position. • I bring to the position my knowledge, experience, professionalism, communicative skills, interpersonal skills, work ethics and high quality work. • I delivered 100%, on time and before due date all reviews and releases of batch records. I incorporated their review and release as well as protocol for R & D. • I initiated changes to many of our S.O.P.’s to make them more efficient and to assure that we were always in compliance with all cGMP’s. • I conducted Monthly meetings with senior staff advising them of existing project progress and initiating recommendations to improve existing procedures and quality audits. The above is an example of how I was able to multitask and thereby ensure expeditious and successful audits. Best Regards, Ignace Vallejo Mobile # 917 359 3028

Highlights:

• Quality Assurance
• Scientist
• Trainer
• Quality Control
• Auditor
• Biology
• Quality
• Manufacturing
• Management
• Microbiology