Here is what I am looking for:

• Experience for creating validation documents for GMP systems (Includes User Requirements, Functional Requirements, IQ, OQ, PQ, Design documents etc.), writing validation plan, validation summary, creating change controls, writing SOPs, work instructions etc.
• Experience in Lab systems (LIMS, LES, ELN, CDS, SDMS etc)
• Understanding of CFR Part 11, Annex 11
• Work in a cross functional team with minimum directions
• Good communication and team player

Email resumes to Reem…@T…com  – Thank you Reema Bains 925-866-8200 ext 228