Primary Responsibilities: Qualification of Temperature Control Units, Quality Control Microbiology and Analytical Equipment, Generation, Review, and/or Execution RTMs, URS, Validation Protocol (IQ, OQ, PQ) and Report, CAPA, Change Control, and Investigate and resolve Discrepancies and Deviations. Commissioned, Decommissioned, performed On-boarding qualification of TCUs (Freezer, Refrigerator, Incubators), QC equipment (such as BioSafety Cabinet, Laminar Flow Hood, Fume Hood), and generated… Show more Primary Responsibilities: Qualification of Temperature Control Units, Quality Control Microbiology and Analytical Equipment, Generation, Review, and/or Execution RTMs, URS, Validation Protocol (IQ, OQ, PQ) and Report, CAPA, Change Control, and Investigate and resolve Discrepancies and Deviations. Commissioned, Decommissioned, performed On-boarding qualification of TCUs (Freezer, Refrigerator, Incubators), QC equipment (such as BioSafety Cabinet, Laminar Flow Hood, Fume Hood), and generated reports with Kaye Validator and Ellab. Executed Remediation Protocol for Rees Scientific Centron Presidio (External Temperature/Humidity Monitoring Probe). Documentation of the qualification test protocol, Calibration/Preventative maintenance SOP, Gap Analysis, and summary reports. Drafted SOPs for Validation Policies, Change Control Procedures, and Systems Operation for proper handling of equipment and validation instruments. Developed and/or reviewed validation deliverables, Validation Master Plans, Qualification Protocols, User/Functional Specifications, Validation Summary Reports, Gap Analysis, Remediation Plans, Risk Assessment, and Training Materials, in compliance with 21 CFR Part 11, GAMP 5 and GMP FDA Compliance Regulations. Assisted in CAPA management by extracting Complaints data from Smart Solve Complaint Management System. Hands-on experience on SharePoint for Change Management, and developed Change Request, Change Review, Control Forms and implemented Change Control Process for the application. Analyzed and reviewed validation deliverables like Validation Plan, Validation Summary Report. Performed SME reviews for TCU qualification protocols, RTMs, URSs, and other validation protocols, and provided path forward for discrepancies and deviations. Performed Periodic Review for Validation and Manufacturing SOPs. Generated work order, update calibration/maintenance event report, and system details on Blue Mountain Regulatory Asset Manager (BMRAM). Show less

Primary Responsibilities: Provided technical support to equipment validation (CQV) of new and existing GMP equipment, performed Batch Record review, On-the-Job Training, Non-Conformities investigation and resolution, validation protocol generation, drafted a Validation Master Plan based on the schedule for commissioning and Qualification (risk-based). Worked with Process Control Specialists (PCS) to develop a system on reviewing of Batch Record (BR) and expediting product release. … Show more Primary Responsibilities: Provided technical support to equipment validation (CQV) of new and existing GMP equipment, performed Batch Record review, On-the-Job Training, Non-Conformities investigation and resolution, validation protocol generation, drafted a Validation Master Plan based on the schedule for commissioning and Qualification (risk-based). Worked with Process Control Specialists (PCS) to develop a system on reviewing of Batch Record (BR) and expediting product release.  On-the-Job Training for each manufacturing process and equipment setup SOPs, were created for effective understanding of technicians.  Supported process development and in-house manufacturing activities in support of Good Manufacturing Procedure (GMP). Reviewed documentation and/or qualification of various equipment such as Spectrophotometer, Manual fitting Inserter, RO/DI system, etc. Drafted SOPs for Systems Operation, and safety precautions to be taken for proper handling of instruments. Drafted facility qualification and validation protocols (HVAC-Cleanrooms) based on the ISO 14644 requirements. Cross-functionally involved with Manufacturing Engineers and Process Engineers to work on non-conformities investigation. Worked cross-functionally with QC, and Production during documentation of the CAPA summary reports in accordance with 21 CFR part 820 requirements. Coordinated with QA and Engineering teams during Root Cause Analysis and use of quality tools (5 why’s, Ishikawa’s Fishbone diagram, Process Failure Mode, and Effects Analysis (PFMEA) etc.) Qualification of HVAC and associated systems such as compressors, vacuum system, air circulation system and TCUs, and Lyophilizer (CIP/SIP). Show less

Primary Responsibilities: Reviewed and approved qualification protocols (IQ, OQ, PQ) engineering documents (URS, FRS, RTM) utilities and manufacturing equipment. Created PFMEA for existing products, determined, justified, and coordinated the purchase and implementation of new equipment and processes jointly with manufacturing teams. Generated and executed CQV Protocols for equipment like Freezers, Incubators, Refrigerators and HVAC. Used Kaye Validator to conduct temperature… Show more Primary Responsibilities: Reviewed and approved qualification protocols (IQ, OQ, PQ) engineering documents (URS, FRS, RTM) utilities and manufacturing equipment. Created PFMEA for existing products, determined, justified, and coordinated the purchase and implementation of new equipment and processes jointly with manufacturing teams. Generated and executed CQV Protocols for equipment like Freezers, Incubators, Refrigerators and HVAC. Used Kaye Validator to conduct temperature mapping studies on various instrumentation (refrigerators, freezers, sterilizers). Cleaning validation of tablet punching machine by swab testing and rinse testing analyzed using HPLC. Aided project engineers and project managers in project development, cost estimate preparation, etc. Assisted packaging engineering department in laboratory testing and validation of new packaging designs. Developed Packaging Process Validation protocols and SOPs. Ensured process operation was completed in full compliance with cGMPs, SOPs, and safety regulations Managed laboratory equipment by maintaining calibration/validation records, initiating maintenance notifications, tracking work orders, and communicating with operations & support to ensure compliance. Show less