Teresa Figueroa

• Retrospective evaluations of OOS (Aurangabad-Indore)
• Retrospective Batch Record evaluation (Takeda and SUN Pharmaceuticals)
• Retrospective LIR’s evaluation (Hetero)

• Creation of procedures for analytical instruments for calibration and Preventive maintenance (i.e., balances and pipettes)
• Write and execute Qualification Protocols of stability Chamber, Freezers, Refrigerators, Warehouse, IQ, OQ, and PQ (Viatris, Sartorius, Elly Lilly Caribe, Romark, Amgen, Fresenius, Medtronic, Ethicon, Cardinal Health, and Pure Cap)
• Qualification of Ovens, Freezers, Incubators, Photostability chambers, etc
• Generation of Qualification Summary Reports
• Generation of Investigations for Protocol discrepancies
• Use and knowledge of ValSuite Software for Ellab equipment

· Write URS, Commissioning and Qualification Protocols (Installation and Operational) for Environmental Chambers, Microscope, NucleoCounter, Bio-Safety cabinets, Manual Fillers, Refrigerators, Freezers, Cryo-carts.

· Execute Commissioning, and Qualification Protocols (Installation and Operational Qualification) for Environmental Chambers, Microscope, NucleoCounter, Bio-Safety cabinets, Manual Fillers, Refrigerators, Freezers, Cryo-carts.

· Generation of Qualification Summary Reports.

· Generation of Investigations for Protocol discrepancies.

• Quality System Expert, Assessment Data Integrity
• Data integrity assessment of Stand-Alone laboratory Equipment/Instruments
• The assessment included the existing electronic data security controls to protect or prevent changes to the stored or generated electronic and evaluation of data capture control
• Evaluation of Qualification program, Qualification packages, SOP’s operation, and instrument control
• Evaluation according to 21 CFR section 211.68, 21 CFR Part 11, USP , PDA Technical Report No
• 80

• Establish the Ex-Lax Qc Laboratory Equipment Calibration and preventive Maintenance program structure
• Perform activities associated with the program: data entry, reports, SOP revision, Training, etc
• Support on general activities related to equipment
• Execute QC laboratory tasks related to the qualification and implementation of Empower 3 FR4
• System Administrator Empower 3 FR4

• In charge of QC/QA laboratories instrumentation to ensure that all equipment is kept in calibrated status
• Create the schedule of all preventives, repair, and maintenance with the outside contractor and Mylan instrumentation personnel
• Prepares monthly Quality metrics related to instrumentation area
• Maintained laboratory instruments and developed new laboratory equipment
• Lead and manage IQ/OQ/PQ activities
• Coordinate calibration and preventive maintenance of QC/QA and related systems
• Revise SOP's against USP, EP/BP, and JP pharmacopeias
• Initiate, manage and complete CAPA's, Trends, Change Control, and Quality impact assessment
• Perform, review or approve equipment investigations due to out-of-tolerance obtained during the calibration
• Responsible for maintaining in calibrated state and preventive maintenance of the stability chamber
• Participate in Internal audits
• Maintain spare parts inventory room
• Attend auditors from several agencies
• Represent to QC area on project teams
• Write, review or approve analytical investigations
• Resolve analytical issues associated with release and stability testing, including OOS/OOT investigations

• Initiate and review all laboratory change control
• Implementation of electronic system software for SOP
• In charge of Internal audits
• Creation of Site Master File
• Help in the implementation of SAP for production
• Creation of Bill of Material (BOM)
• Training to all personnel of the SOP program
• Work with Complaints
• In charge of the Laboratory data system as administrator (Millennium, Empower1)
• Supervises and coordinates all activities related to the Finished product and stability area
• Review analytical data
• Lots release
• Write analytical investigation

• Perform tests on raw materials, intermediates, blends, and finished products within the assigned area
• Review and process data
• Interpret test results, ensure that they meet specifications, enter data into the computer, maintain instrument logbooks, laboratory worksheets, and all relevant documentation according to cGMP documentation practices, review all information, and compile data into report form
• Troubleshoot instrumentation and investigate aberrant sample results
• Serve as a primary resource for the team to evaluate laboratory analytical issues in collaboration with analysts and management
• Perform analytical investigations
• Activities include drafting Analytical Investigation Reports (AIR) text, performing action steps, drawing justifiable conclusions based on data, and approving action steps in AIR Phase 1
• Review paperwork and documentation from other Chemists
• Participate in quality and efficiency improvement initiatives
• Calibrate laboratory equipment as necessary

• Perform tests on raw materials, intermediates, blends, and finished products
• Review and process data
• Interpret test results, ensure that they meet specifications, enter data into the computer, maintain instrument logbooks, laboratory worksheets, and all relevant documentation according to cGMP documentation practices, review all information and compile information into report form
• Act as a resource to team members and other Chemists
• Review and approve paperwork and documentation from other Chemists
• Troubleshoot instrumentation and investigate aberrant test results
• Perform analytical investigations
• Perform Activities such as drafting Analytical Investigation Report text, performing action steps, and drawing justifiable conclusions based on data
• Calibrate laboratory equipment as necessary