Electric Automotive Manufacturing (OEM)- Overall Operations management of Quality, Production, Supply Chain, New Product Development, Maintenance and After Sales Service departments with focus on continuous staff training and development to ensure compliance to company policies and procedures- Manage turnkey projects to commission a 60,000 square feet facility for electric vehicle manufacturing. Projects included regulatory approval, resource acquisition and training, utility… Show more Electric Automotive Manufacturing (OEM)- Overall Operations management of Quality, Production, Supply Chain, New Product Development, Maintenance and After Sales Service departments with focus on continuous staff training and development to ensure compliance to company policies and procedures- Manage turnkey projects to commission a 60,000 square feet facility for electric vehicle manufacturing. Projects included regulatory approval, resource acquisition and training, utility commissioning, implementing procedures and streamlining process flow - Operations management for 60,000 square feet manufacturing facility and service departments based in 5 different cities with combined staffing of 220 FTEs. Show less

FDA registered 503B sterile compounding Pharmacy- Responsible to generate and execute IQ/OQ/PQ protocols for two (2) aseptic processing facilities as per Site Master Validation Plan (SMVP), perform qualifications and routine requalification’s on new equipment’s.- SME for critical equipment’s such as steam sterilization autoclave, Depyrogenation ovens, automated washer-dryer, refrigerators, freezers, incubators and Flexicon PF7 Peristaltic Aseptic Filler, draft and revise SOPs to… Show more FDA registered 503B sterile compounding Pharmacy- Responsible to generate and execute IQ/OQ/PQ protocols for two (2) aseptic processing facilities as per Site Master Validation Plan (SMVP), perform qualifications and routine requalification’s on new equipment’s.- SME for critical equipment’s such as steam sterilization autoclave, Depyrogenation ovens, automated washer-dryer, refrigerators, freezers, incubators and Flexicon PF7 Peristaltic Aseptic Filler, draft and revise SOPs to standardize production processes to ensure critical quality attributes are met. - Support production to evaluate current processes and implement continuous improvements and control strategies to increase right first time (RFT) metrics.- Proficient in use of Kaye Validator AVS to validate equipment’s pertaining to aseptic processes and new product development- Perform in house calibration to save $30,000 per year on sterilization equipment and other temperature-controlled equipment’s.- Aseptic process coordinator for processing media fill campaigns conducted on site to evaluate the aseptic assembly and operation of critical sterile equipment’s and operators.- Perform data analytics to provide rationale and scientific justification for final reports pertaining to validation studies.- Responsible for the Master Equipment List and Calibration database to track calibration deadlines for equipment’s, schedule and perform timely calibration on critical production equipment’s.- Handled periodic calibration and revalidation for equipment’s located at two (2) aseptic facilities producing sterile injectables. Show less

FDA registered 503B sterile compounding Pharmacy- Lead as an investigational expert to draft NOE’s, deviation reports and close CAPA’s within strict deadline- SME expert for incoming quality during FDA audit, project expert to develop incoming quality unit within strict deadline- Development and implementation of methods for sampling, inspection, testing and evaluation of incoming materials- Created and trained personnel’s on new forms and SOP’s for incoming container… Show more FDA registered 503B sterile compounding Pharmacy- Lead as an investigational expert to draft NOE’s, deviation reports and close CAPA’s within strict deadline- SME expert for incoming quality during FDA audit, project expert to develop incoming quality unit within strict deadline- Development and implementation of methods for sampling, inspection, testing and evaluation of incoming materials- Created and trained personnel’s on new forms and SOP’s for incoming container closure systems inspections - Implemented new QMS using USP and ICH regulations to fulfill key regulatory requirements- Responsible for qualifying global API manufacturers to make sure raw materials meet requirements, track supplier historical performance and validate key incoming quality attributes data to re-qualify suppliers- Involved in multiple projects with supply chain and quality control unit to qualify API manufacturers based overseas Show less

Solid dose and Liquid manufacturing pharmaceutical Company - QA in process auditing manufacturing and packaging process, point of contact for QA management on 2nd shift to execute corrective actions for verification failures, quality issues and deviations from cGMP practices - Final review and release of lab reports, CoA, MBRs and PBRs, three BRs submitted to FDA during audit with no observations - Observed six deviations from cGMP practices for solid dose products that resulted… Show more Solid dose and Liquid manufacturing pharmaceutical Company - QA in process auditing manufacturing and packaging process, point of contact for QA management on 2nd shift to execute corrective actions for verification failures, quality issues and deviations from cGMP practices - Final review and release of lab reports, CoA, MBRs and PBRs, three BRs submitted to FDA during audit with no observations - Observed six deviations from cGMP practices for solid dose products that resulted in CAPAs to improve DOPs and BRs- Drafted a proposal to revise a SOP to increase the waste stream for QA reserve samples with compliance to ICH Q7 sec 11.7, EU Annex 19 and FDA 21CFR211.170 regulations, executed destruction of 30% of total reserve samples to reduce compliance risk Show less

Automotive tier II equipment manufacturer - Monitored QMS software for tracking daily rejections to draft RCCA report for scrap parts and route rework parts to dedicated workstations with rework instructions, draft monthly and annual reports for management- Supported a team that implemented TPM to improve equipment utilization to achieve a target of 95% effectiveness on the CNC and VMC machine, drafted troubleshooting guides and trained employees- Revised Standard operating… Show more Automotive tier II equipment manufacturer - Monitored QMS software for tracking daily rejections to draft RCCA report for scrap parts and route rework parts to dedicated workstations with rework instructions, draft monthly and annual reports for management- Supported a team that implemented TPM to improve equipment utilization to achieve a target of 95% effectiveness on the CNC and VMC machine, drafted troubleshooting guides and trained employees- Revised Standard operating procedures (SOP) for VMC equipment with Quality requirements and Safety standards- Created and updated documents including work instruction, process control, PM documents and training documents Show less

Automotive original equipment manufacturer (ISO/TS 16949)- Involved in PPAP, Capability studies, maintaining quality standards: ISO/TS 16949, Machine maintenance scheduling, process validation, FMEA, DOE, RCCA, CAPA, MSA and Gage R&R- Supported the manufacturing engineering team to achieve yearly savings of $ 18,500 by cutting cost of CNC milling operation using Six Sigma DMAIC methodology, participated in validation and verification activities after approval of change control-… Show more Automotive original equipment manufacturer (ISO/TS 16949)- Involved in PPAP, Capability studies, maintaining quality standards: ISO/TS 16949, Machine maintenance scheduling, process validation, FMEA, DOE, RCCA, CAPA, MSA and Gage R&R- Supported the manufacturing engineering team to achieve yearly savings of $ 18,500 by cutting cost of CNC milling operation using Six Sigma DMAIC methodology, participated in validation and verification activities after approval of change control- Completed multiple projects using continuous improvement, significantly reducing the operating cost by 6% and COPQ by 20% Show less

- Collected data using measurement tools to draft control charts, drafted monthly metrics and trend data reports for six sigma black belt and process owner- Identified out of control processes and executed strategies to eliminate them, achieved 99% conformance to design specifications