Jignesh Soni

Lead five Quality Control, Microbiology, and Metrology managers and guide function teams of about 40 members total. Successfully managed daily laboratory activities and upheld cGMP compliance, resulting in smooth responses to internal and external audits (FDA and Health Canada). Reviewed and approved QMS documents, such as OOS/OOT reports, change controls, lab event investigations, and SOPs. Complied with Regulatory Affairs requirements for ANDA and NDA filings. Support QC leadership in attracting, training, and retaining talent. • Strengthened investigation reports and implemented appropriate corrective actions to eliminate future occurrence of mistakes. • Managed 25 live product profiles for raw materials, finished products, stability samples, and Microbiology testing. • Directed testing for 6 new product profiles yearly, which contain extensive process validation samples. • Oversaw monthly testing activity for an average of 80 finished products and 100 stability samples. • Tracked CapEx activities and handled department budget to guarantee the efficiency of QC and Microbiology departments. • Spearhead monthly quality metrics report to track trends in productivity, service levels, human error rates, OOS/OOT rates, and PQC. • Reduced rate of laboratory-related investigations over 3 years by 10 percent, resulting in a massive increase in productivity.

Leading a group of 18 Quality Control analysts, supervisor, & group leader and working on solid dosage drug products for the US Market. This position reports to the Quality Control director. • Quality representative in the site management team to provide technical guidance as and when needed for successful execution of Quality Control projects. • Coordinates various types of laboratory testing related to raw materials, in-process, finished products, process validation, stability and cleaning verification with minimum turnaround time and maximum manpower utilization. • Improved and implemented laboratory procedures and achieved highest level of compliance. • Evaluates and conducts various OOS/OOT investigations, deviations, CAPAs, and change controls. • Evaluates and approves all analytical procedures, SOPs, various protocols and reports to ensure highest level of compliance with FDA and cGMP requirements. • Closely interacts with R&D, Regulatory Affairs, manufacturing and project management departments to ensure timely completion of all activities and meets the organizational goals. • Supervises sub ordinates, determining workloads, assigning responsibility, sets departmental budget and performance goal of the staff. • Provides training, monitor progress, evaluate performance and initiate corrective or disciplinary actions, as needed. • Participates in cross functional teams to drive quality projects, quality metrics and continuous improvement projects. • Develops and maintains robust systems for all time reediness for any regulatory inspections. • Directs laboratory staff on day-to-day operations to ensure accuracy and completion of each project. • Interacts with senior management to update the day to day laboratory activities and progress • Ensures compliance to site EHS, OSHA and DEA regulations on day to day activities.

Directed laboratory staff up to 10 employees on day-to-day laboratory operations, outside contract testing, equipment calibration and sample management functions to insure accuracy and appropriate product and sample testing is performed, completed, and reported in a timely manner. Executed all types of laboratory testing related to raw materials, in-process, finished products, stability samples and cleaning verifications (Instrumental and wet analysis) with minimum turnaround time and maximum manpower utilization. Reviewed QC testing and other testing reports for accuracy, completeness and compliance to requirements to ensure that quality standards, efficiency, and schedules are met. Maintained all laboratory notebooks, reports, instrument log books and other documentation in accordance with CGMP. Trained and developed QC personnel and served as a key trainer in CGMP, SOP and various technical training related to laboratory operation. Worked in conjunction with site Quality Assurance to implement, monitor, and update of the laboratory system. Successfully implemented improved laboratory procedures and supported organization to achieve highest level of compliance. Executed, drafted and closed various laboratory OOS/OOT investigations, deviations, CAPAs and change controls. Prepared various protocols, reports, methods, and SOPs as per the FDA and CGMP requirements. Completed successful FDA inspections with zero 483. Administered DEA materials for use by QC personnel.

Assisted subordinates during method development-validation-transfer-remediation for HPLC, GC, UV and Dissolution test procedures of solid dosage pharmaceutical products. Prioritized analytical activities consistent with ANDA filing timeline and business need for numerous first-to-file projects. Coordinated testing related to ANDA batches and stability studies required for ANDA filing. Prepared and reviewed method validation and transfer protocols/reports to support ANDA submission. Compilation of various ANDA submission documents, Quality Overall Summary preparation and submission to Regulatory Affairs. Conducted various laboratory investigations related to Out-of-specifications, suspected test results and laboratory errors. Reviewed updates in Pharmacopoeias (USP/EP/BP/JP) and initiated necessary compliance procedures. Developed, directed, and evaluated training programs. Completed analytical instrument qualification, routine instrument calibration, and maintenance on periodic basis.

Conducted various Analytical testing for raw materials, tablets, capsules and stability samples of solid dosage pharmaceutical products. Organized work and performed tests using latest analytical testing methods such as HPLC, GC, Dissolution, Malvern Mastersizer, Disintegration, UV, TLC and FTIR for finished, stability and in-process samples of solid dosage forms. Documented data and reported results properly into lab note books. Worked on projects and assignments as per management request. Performed laboratory instrument routine maintenance, calibration and troubleshooting. Transferred analytical methods from international sites of Sanofi-Aventis to local site. Hands-On Experience with Laboratory Instruments: • High Performance Liquid Chromatograph (Waters, Shimadzu, Agilent) • Empower, TotalChrom, Class-VP and Chemstation data acquisition software • Gas Chromatograph (HP 5890 and 6890 plus Series with head space, Chemito 8510, Shimadzu GC 17A) • Dissolution Apparatus-1, 2, 3 & 7 with Dissolution Auto Sampler (Distek, Agilent) • UV – Visible Spectrophotometers (Shimadzu 1601, Agilent) • Fourier Transform Infra-Red Spectrophotometer (Perkin Elmer) • LC-MS (Waters) • Particle Size Analyzer (Malvern) • Differential Scanning Calorimeter