- Having 3 years of experience in Validation with strong background in Pharmaceutical Industry.
- Strong understanding of 21 CFR Part 11, Validation Strategies and Documentation, GAMP, GxP’s (GCP, GLP and GMP),OSHA requirements .
- Emphasis on manual and automated testing with thorough understanding and knowledge of Validation Life Cycle and Software Development Life Cycle (SDLC).
- Skilled in developing Standard Operating Procedures (SOPs), policies and working instructions to ensure compliance with FDA regulations.
- Comprehensive knowledge and extensive experience in technical writing of Validation protocols (Computer System Validation (CSV), Cleaning Validation, CIP, Sterilize IN Place (SIP), Design Qualification (DQ), Facility and Utility Qualification, Factory Acceptance Test (FAT’s), Site Acceptance test (SAT’s), Installation Qualification - IQ, Operational Qualification - OQ), Performance Qualification (PQ), Validation Master Plan (VMP), SOP’s, SAT, Test Summary Report,, Test Plans, Test scripts, and Requirement Traceability Matrix (RTM) in FDA regulated environments.
- Experience in executing Cleaning Validations, CIP’s, Sterilize in Place (SIP’s) and Temperature Mapping.
- Experienced in performing periodic reviews and GAP analysis for identifying compliance gaps, developing Corrective Action and Preventive Action (CAPA) and implementing them.
- Extensive Experience in working with PowerPoint, Word and Excel.
- Excellent interpersonal, organizational, verbal and written communication skills.
- SAS Programming
- SQL Programming Proficient in MS- Office
- Reporting Tools - Cognos 10.1.1 (Report Studio
- Framework manager
Confidential, Waco, Texas
- Currently developing the IQ and OQ Validation Protocols for Freezers, single door and double door Refrigerators.
- Performed Temperature Mapping on Warehouse, Refrigerators and Freezers using Temp tales.
- Developed the User Requirement Specifications for Incubators and created the RTM.
- Executed Cleaning Validation’s on Tanks, Homogenizer and High Shear Mixer used in Bulk formulations.
- Performed the CIP cycle using CIP skid on Castor oil tanks and High shear mixer.
- Resolved the Deviations during validation and developed the deviation reports and Cleaning Validation Final Reports.
- Performed the SIP half cycle on 240L, 600L, and 1200L tanks, Dry Heat Oven and Autoclaves using KAYE Validator and Steam Controller.
- Calibrated the Thermocouples before the Qualification to the set temperature and performed Verification after Qualification.
- Analyzed the data from the KAYE Validator and created the performance graphs for each cycle of the equipment to determine the sterilization achieved.
- Developed the Deviation and SIP Final Reports.
Confidential, La Verne, California
- Created technical writing documents in compliance with cGMP.
- Executed the IQ and OQ of the FAT of the Solid Dose line equipment.
- Developed the commissioning protocols for Unscrambler, Systech system and Labeler for Solid dose line equipment.
- Reviewed, edited, and formatted Validation documents, SOPs, Forms and Logbook templates.
Confidential, Salt Lake City, Utah
- Execute validation activities involving the qualification of facilities, utilities and equipment’s .
- Executed the IQ, OQ and PQ of Delta Matrix 2 Fabrication and Pouching Machine for different sizes.
- Involved in Protocol development and execution of size specific Performance Qualification of Delta Matrix 2 Fabrication and Pouching machine using Validation Master Plan.
- Involved in Protocol development for HIBAR Filler & Press change Modification Protocol using VMP.
- Executed IQ and OQ protocols of HIBAR Filler & Press and its modifications and NJM Labeller and check for zero defects after performing PQ run.
- Reviewed the Qualification Project Plan for OPTEL Vision Serialization System and developed the RTM for this equipment.
- Performed the IQ and Software Validation for OPTEL Vision Serialization System.
- Handled the tasks of testing hardware and software components and performed the Operational Qualification of the system.
- Developed Protocol for transfer Pumps and performed the dry run to qualify the pumps.
- Developed and Updated the SOP for the Hibar Filler & Press equipment modifications.
- Recorded and maintained record of company Vendors and their products.
- Updated the software versions and all data received from the vendor in compliance with FDA to achieve data integrity.
- Documented the protocols, software and all the data received for the product by the vendor for auditing.
- Performed the responsibilities as per SOP and company’s policies and procedures.
- Created Weekly Status reports, Memo, Deviation reports and Final Summary reports for the performed executions.
- Involved in preparing and storing the data to ensure data quality.
- Involved in Daily, weekly and Monthly meetings.
Confidential, Seymour, Indiana
- Executed the Installation Qualification (IQ) and Operation Qualification (OQ) for various equipments.
- Reviewed and Updated the Protocol and SOP's.
- Involved in writing the IQ and OQ protocol for USP Water System using the Validation master Plan (VMP).
- Redlined the Engineering drawings.
- Reviewed the graphs, Engineering drawings and vendor protocols for Qualification.
- Involved in assisting a Test method template for future validation requirements.
- Conducted training on good documentation and good testing practices.
- Underwent training in storing the data for an audit to ensure data integrity and data quality
- Participated in establishing standard quality and validation practices.
- Involved in weekly and monthly meetings to discuss the work plans.
- Interacted with the Operators, Production and Maintenance departments to ensure accurate Validation results.
- Prepared Deviation reports after execution of protocols.
- Generated the Validation Summary and Validation Final reports.
- Analyzed the Validation data and Report results.
- Prepared, reviewed and executed Analytical method validation plan and/or Protocol.
- Implemented Standard Operating Procedure (SOPs) of validation protocols to enhance and control the quality of the services to ensure compliance with FDA regulations.
- Generated and executed the HPLC and GC Test method validation protocols and created reports to support FDA submissions.
- Involved in project scheduling and deciding Timelines for activities related to validation.
- Attended daily status meetings with Project management on testing updates.
- Involved in preparation of Validation Summary Report (VSR).
- Observed the procedure involved in Research and Development department of developing a new method and formulation at pilot scale by following GLP and GMP.
- Gained knowledge in the Production department about the production of beads by following the SOP and coating of beads and drying them following GMP.
- Carried out Dissolution and Disintegration of the tablets manufactured and reviewed the SOP’s in the Quality Control department.
- Observed the final packaging procedure of the tablets into containers and bottles followed by labeling in the Packaging and Labeling department.