Heriberto Rodriguez Rodriguez

NATIONAL GUARD

May 2012 to 2000
Health Care Specialist
NATIONAL GUARD
Evergreen Park, IL
Jan 2014 to Mar 2014
Delivery Driver
NATIONAL GUARD
Evergreen Park, IL
May 2013 to Sep 2013
Sales Associate
FREELANCE CONSTRUCTIONNaperville, IL
May 2010 to Oct 2012

Army 68W Course
Sam Houston, TX
2012 to 2013
Certification in Health Care

Microsoft Office, Computer Repair

J L B electrical services inc.
Guayama Puerto Rico
Aug 2002 to Mar 2014
supervisor electricista

instituto de educacion universal
Bayamn, PR
1985 to 2014
grado asociado en electricidad in perito electricista
instituto de educacion universal
Bayamn, PR
perito electricista in subestaciones 13.2kv

Hoist lift truck

Aug 2014 to 2000
CNC Set-Up Operator

Chicago manufacturing Institute
Chicago, IL
1994 to 2006
Certification Industrial Mechanical Inspection. in Computer technology

IPR Pharmaceuticals, Inc

2004 to 2012
Regulatory Affairs Officer
IPR Pharmaceuticals, Inc

2001 to 2004
RA Specifications Associate
IPR Pharmaceuticals, Inc

1997 to 2001
Chemist

University of Puerto Rico
Cayey, PR
1993 to 1997
Bachelor Degree in Science in Major in Chemistry

Broad knowledge of the US Code of Federal Regulations Title 21, EU GMP, FDA and international guidelines, ICH guidelines, Japan PAL Site Accreditation, Vast experience in Change Control and regulatory implications assessments for the US, EU, Japan and rest of the world (RoW) markets. Broad experience in regulatory submissions such as New Drug applications (NDA), Annual Reports (AR), Change being Effected (CBE) and Prior Approval Supplements (PAS); also Annual Product Reviews (APR), Site Master Files (SMF), Drug Master Files (DMF), Periodic Safety Update Reports (PSUR), registration documentation, GMP Certificates, TSE/BSE declarations/ certifications, Experienced in quality systems such as SOPs, investigations, CAPAs, and specifications and analytical methods systems. Experienced in Internal auditing, vendor qualification and certification, and reduced testing program. Experienced in stability data review and trending analysis. Strong communication skills, adapts easily to new environments. Computer literate. Proficient in Spanish and English.