Edwin Camacho Email & Phone Number

- Responsible for the coordination activities related to the QAU including the verification, assessment and compliance of analytical testing in accordance with USP/NF, EP, BP and JP Pharmacopeias, compendiums or other Standard Testing Procedures.- In charge of Internal Audits of the analytical laboratories in accordance to internal SOP's.- Review of data from R & D, Formulation, QC, Raw Materials, Synthesis and Microbiology to ensure results are accurate, complete and complied with cGMP, GLP, Azopharma policies and procedures as well as FDA regulations.- Review and approval of Protocols and Reports including Method Validation, Method Development, Method Transfer and Characterization.- Review and approve Laboratory Investigation Reports (OOS/OOT, Deviations, etc.)- Mentors and train other QA Associates on data auditing functions.- Reports/escalates errors to appropriate department for resolution.- Communicates with management any problems found during data review that might affect laboratory operations.- Assists QA management on special projects.

- Batch record review and release for Bulk, Packaging and QC laboratory.- Responsible for reporting and writing into Trackwise System Complaint(s) and Operational investigation(s).- Assists production during process troubleshooting and the investigation of quality incidence.- Alert Management on a real time basis of developing discrepancies and process problems.- Actively participate in the development of corrective actions.- Responsible to communicate and initiate any deviation identified during the manufacturing process or during the review of the SOI (Standard Operating Instructions).

- Responsible for overall QA/QC, sanitation operations and production lines from different products manufactured by Coca-Cola.- QA inspection of five product lines, holding and concentrated (raw materials) areas according to Coca-Cola policies and procedures.- In charge of quarantine (hold) and concentrated (raw materials) inventory.- Responsible for review and approve of all the tests performed in the laboratory such as raw materials, finished products and microbiology using the Statpak software.- Scheduling, Planning and Evaluation of fifteen (15) laboratory technicians and ten (10) sanitation technicians.- Verification, review and checking of all the documentation generated in the laboratory for accuracy.- In charge of Internal laboratory and market audits.- In charge of Water Systems Plants.

- Responsible for overall Quality Control Laboratory Operations (Planning, Scheduling, Coordination) to ensure that all work is done in a timely manner and in compliance with cGMP, GLP, OSHA, SOP's, USP/NF, FDA regulations, companies STM's and policies.- In charge of the Oral Contraceptive Project Launch, Cleaning Validation Program and Method Transfers from R & D to Quality Control.- Hands-on experience in the performance, written, check and update of standard test methods/procedures, specifications as well as in the developing and implementation of Standard Operational Procedures (SOP's) in coordination with the Document Control Department.-Review and release of all the analytical data for accuracy generated in the QC laboratory before release it to QA for final disposition.- Lead investigations, interpret results and recommends final disposition for Out of Specification/Trending results.- Hands on experience conducting OOS/OOT investigations and do final reports using the Trackwise system for OOS/OOT, deviations and CAPA investigations.-Experience and knowledge in the use of instrumentation and equipments such as HPLC, GC, FTIR, UV/VIS and Dissolution systems such as Hanson, Vankel and Distek.-Experience doing QC laboratory internal audits.-Ensured that all personnel are properly trained.

- Analysis of intermediate, finish product and stability samples of transdermal patches (Drug Delivery Systems).- Experience and knowledge in the use of Water HPLC systems with Millenium software.- Validation and Method Transfer projects.- Troubleshooting and general maintenance of Water HPLC systems.- Document, record, review and report test results for accuracy in compliance with cGMP and FDA regulatory requirements.-

- Support domestic and international sales managers in their quest to sell Quantachrome instruments for Particle Characterization.- Provides timely testing services for samples on the specific instruments that will be sold to the customers.- Coordinating with the sales managers as to turn around times for completion of testing and providing data interpretation to both sales managers and customers.- Provide test services for Surface area, Pore Size distribution, Density and Chemosorption for the pharmaceutical, food, cosmetic, rubber, petrochemical, etc.- Reports directly to the Director of Science and Technology.

- Work in the QA/QC departments for analysis, review, check and assessment for the Water Quality Monitoring Laboratory.- Review, check and approve all the data collected by the field staff for accuracy verifying that all the data collected are withinspecifications and no discrepancies exists using different statistical method procedures.

- Engaged in performing equipment calibration, documentation, sampling and analysis of raw materials, intermediates and finish products using ACS spectrophotometer, GC, FTIR, UV/VIS, Karl Fischer and Brookfield Viscometer.- Review and approve batch records for release and during internal audits.- In charge of Inventory Control and the Quarantine area according to Colorcon policies and procedures.- In charge of information transfer for Certificate of Analysis.- Review, check and disposition of Batch Records and Raw Data generated in the QC laboratory and Production areas according and in compliance with cGMP, FDA regulations and Colorcon policies and procedures.-Employee of the year 1991 and 1994.