Perform Data Integrity audits on different systems (Laboratory training procedures/documentation, LIMS, data review etc) among different departments (QC Chemistry, EM, etc.)Support the data integrity program, including performing routine data integrity audits.Reviewing, editing and approving technical documentation supporting Commercial Operations, Quality Control as well as Validation activities such as QC instrument qualification, IOQ/PQ documents, and computerized systems assessments… Show more Perform Data Integrity audits on different systems (Laboratory training procedures/documentation, LIMS, data review etc) among different departments (QC Chemistry, EM, etc.)Support the data integrity program, including performing routine data integrity audits.Reviewing, editing and approving technical documentation supporting Commercial Operations, Quality Control as well as Validation activities such as QC instrument qualification, IOQ/PQ documents, and computerized systems assessments while ensuring compliance with applicable regulatory requirements. Show less

Attending Networking Events Researching Industry LeadersTracking Industry TrendsParticipating in Industry Discussions

Initializes, verifies, approves andmaintains the Laboratory Information Management System (LIMS) Stability Program database files, Participates in validation activities to maintain the LIMS in a validated state. Provides training to personnel on various computer systems related to the generation, storage and retrieval of analytical data. Reviews laboratory results and data packets generated by Pharmaceutical Analysis (PA) staff to ensure that data are accurate, reliable and all method SOP… Show more Initializes, verifies, approves andmaintains the Laboratory Information Management System (LIMS) Stability Program database files, Participates in validation activities to maintain the LIMS in a validated state. Provides training to personnel on various computer systems related to the generation, storage and retrieval of analytical data. Reviews laboratory results and data packets generated by Pharmaceutical Analysis (PA) staff to ensure that data are accurate, reliable and all method SOP requirements have been met. Compiles, evaluates and statistically interprets technical data for memos and reports, and provides critical technical documentation in the form of the same to support world-wide product registration efforts.- Interacts closely with R&D IS and external user groups or consultants to communicate issues and/or requirements; and proposes modifications to improve or enhance computerized system capabilities. - Generate and evaluate accurate and precise data for samples used in stability, clinical and toxicological studies using validated analytical procedures.- Work directly with manager/supervisor to maintain the integrity of the LIMS stability database.- Reviews laboratory results and data packets generated by Pharmaceutical Analysis (PA) staff to ensure that data are accurate, reliable and all method SOP requirements have been met.- Compiles, evaluates and statistically interprets technical data for memos and reports, and provides critical technical documentation in the form of the same to support world-wide product registration efforts.- Actively participates in the evaluation, modification and validation of new modules or versions of computerized systems. Show less

- Analyze the quality of drug products for clients following compendial and provided methods.- Performed a wide range of analytical tests (HPLC, PMT, VIS, OSM, Titration, PSD, Ph, Physical Appearance, PWG,) on clinical and registration products.- Ensure all data is generated/reported according to cGMPs and departmental SOPs.- Assist and train personnel on various computer systems, laboratory equipment and techniques.- Generate and review departmental SOPs, analytical methods… Show more - Analyze the quality of drug products for clients following compendial and provided methods.- Performed a wide range of analytical tests (HPLC, PMT, VIS, OSM, Titration, PSD, Ph, Physical Appearance, PWG,) on clinical and registration products.- Ensure all data is generated/reported according to cGMPs and departmental SOPs.- Assist and train personnel on various computer systems, laboratory equipment and techniques.- Generate and review departmental SOPs, analytical methods, and other critical documents.- Became a key user in the Labmanager system. Trained others in the system and performed change controls. - Initialization of registration and clinical lots into the Labmanager system. Show less