With over 24 years of hands on experience in positions of increasing responsibility in Pharmaceutical, Bio and Medical Devices companies. Areas of expertise includes: Quality and compliance (FDA /21 CFR ,809/ICH, GxP’s), CSV (Part 11 and GAMP5) and Serialization (DSCSA), Technical Support (SME for manufacturing and quality areas), Audit in manufacturing and lab areas. Other Quality areas: revision/approval of SOP and Qualification documents, CAPA investigations (Trackwise/ 5 Why, Fish bone, DMAIC, FMEA), Change Control of documents (DocSpace/Documentum). Lead the Development and implementation of trainings programs for manufacturing and lab areas. Great communication skills, time management, personnel supervision, and organizational skills. Strong leadership background, know how to handle problems quickly and efficiently.

Highlights:

• Quality
• Compliance
• Validation
• Qualification
• 21 CFR Part 11
• Change control
• CSV
• 21 CFR 210,211, 809