Quimico Analista / Quimico de Transferencias analiticas
10-2010 - 02-2016 Diseño/Ingeniería civil/Ingeniería industrial Key achievements
Successful Launch of Tivicay in Mexico, coordinating activities locally, across GSK ICAT Team and Transfer Site to achieve Tivicay Analytical Tech Transfer in a record time to avoid a delay in Launch in Mexico.
Successful results in Anoro Analytical Tech Transfer, completing the requirements for Launch in Mexico in the Q4 2015.
Stock out of Relvare in Mexico Prevented re-establishing analytical capabilities required for analytical testing of Ellipta products being full trained, working on the immediate and corrective actions to be able to test and release the product after a complete assessment of the capability at site. Become Lead User of the Ellipta Equipments at Xochimilco Site.
Worked in team to create and have approved STP to get a new set of specialized equipments and to complete the current equipment sets in place own by Xochimilco. Currently, following up the purchase of the Back-up set for Ellipta equipments to complement the instruments for Testing at Xochimilco.
Full and successfully trained in Andersen Cascade Impactor at Zebulon for Particle Size Distribution Test on Advair (Seretide Diskus).
Lead Finish Product Laboratory Back-up rol Dic 2013 - Jan 2015. In daily basis my activities and responsabilities were reviewing and approving analytical release and stability reports, emitting and approving release Certificate of Analysis, helping on planning weekly analysis program, attending planning and demand meetings negotiating delivery dates for release products, supply monthly KPIs Lab data for Quality Council, supporting/directing to the right people analyst in troubleshooting and systems managing, sending, following and working with third parties for specific test required for release of some products, participating in OO’s at the lab and the Quality Deviations related to the Laboratory failures. Leading Tier 1 and Lab Staff on Leader Holidays or absence.
Local Equipment Administrator. Accountable to perform the Data Back up activities stated in the local program for the instruments in all the Physicochemical Laboratories, submitting, assigning profiles to new staff based on their activities and responsibilities in the use of instruments / equipments, managing the changes in systems and documentation related. (UV and HPLC and GC PCs before One CDS Project Implementation)
Participate in the Validation Plan for OneCDS implementation at Xochimilco
CAPA Verifier for Lab Quality Control area
Member of N2 Audit Team and L1 Auditor at the Laboratory. Leading N1 audits for any of the 3 Finish Product Laboratories. Leading or participating in L2 audits across GMS Xochimilco.
Responsible of Antibiotic (Cephalosporin and Betalactams) Laboratories Management. Mar 2011-Sep 13 Routine analysis of Finish Product, Database systems Creation and management for Reference Standard consume and supply columns in use and stock, reagents based on the use in the lab. 5S certification gotten in both Labs at the same time. Third Parties interactions for product testing. Following the process of supply of Reference Materials Placing orders at the RMG to maintain the stock, creating/providing technical information for importation licenses when required. Attending L1, L2 and L3 and L4 as the responsible of these laboratories in collaboration with my Leaders.