Krupali Patel Email & Phone Number

Boston, Ma, Us

Hatboro, Pennsylvania, Us

Ann Arbor, Mi, Us

• Author and review IQ, OQ, PQs documents and operating procedures for new and existing equipment in GMP Manufacturing and GMP Quality Control Laboratory in accordance to ISPE and ICH guideline and 21 CFR. • Lead GAMP validation initiative of uPLC instrument and Water’s Empower software in accordance to 21 CFR with primary focus on improving data integrity.• Track, schedule and ensure on-time completion of routine equipment events, such as qualification, calibration, and preventative maintenance. • Maintain documentation and equipment files (such as drawings, O&M manuals, equipment logbooks and service records) in accordance with GMP record keeping practices• Maintain Equipment System to support GMP manufacturing and QC testing ensuring all equipment complies with GMP Standard Operating Procedures and Policies• Execute equipment qualifications, calibrations, preventative maintenance and performance verification of new, existing and repaired equipment.• Coordinate on-site calibration and maintenance services with service providers and aid equipment vendors and contractors during onsite visits. • Provide technical guidance and assistance for GMP Manufacturing and GMP Quality Control Laboratory staff with troubleshooting and/or continuous improvement of equipment operations.• Manage temperature and humidity monitoring system for GMP equipment including documentation and investigation of alarms. Responded to equipment and facility monitoring system alarms.

Toronto, Ontario, Ca

• Analyzed production systems, layout and packaging processes to make continuous improvements focusing on Safety, Quality and Productivity• Coordinated with internal clients and external vendors to develop and implement engineering solutions such as, modification to production equipment to improve production output and enhance employee safety• Conducted Installation and Operational Qualifications (IQOQs) on new and existing production equipment to ensure performance of equipment for quality consistency• Implemented the 5S system to optimize production storage space and minimize production related downtime• Performed quantitative/qualitative analysis of production data and shift reports to track gaps for improvements in production management and downtime• Created and modified SOP (Standard Operating Procedures) to ensure operating compliance, and train more than 300 technicians in classroom setting• Developed parts and tools management system that lead to the reduction of production downtime

Waltham, Massachusetts, Us

• Led root cause investigations and performed quality risk assessments to quantify and resolve issues related to manufacturing processes• Conducted statistical process analysis using MINITAB and drafted reliability reports for review in leadership quality reviews• Analyzed manufacturing data records and production data sheets to identify failures and measure process inefficiencies used to identify improvements in manufacturing procedures • Formulated standardized manufacturing procedures for new products based on process control parameters and product specs, to ensure successful transition from development into commercial products

Waltham, Massachusetts, Us

• Drafted Standard Operating Procedures (SOPs) for routine operations of manufacturing equipment to ensure quality production, safety and compliance to Good Manufacturing Practices (GMPs)• Verified technical and procedural accuracy of SOP of manufacturing machinery/equipment by auditing the operational process of the equipment• Facilitated multi-departmental meetings to implement modifications to GMP documentations in response to Management of Change practices• Developed methodology for quantitative assessment of SOP and GMP documentation management to evaluate employee performance, decision making strategies and resourcing

Waltham, Massachusetts, Us

• Performed various work on the packaging line according to established standards and Good Manufacturing Practices to achieve production targets• Ensured all procedures and SOPs were followed to achieve quality goals