Janki Bhavsar Email and Phone Number

● Analyze in-process material, Raw materials &finished goods on a routine basis as well as when non-routine analyses are required.● Conduct a review of and track Good Manufacturing Practices(GMP) Documentation, including Batch Manufacturing Record (BMR), Batch Packing Record(BPR), Certificate of Analysis(COA), Annual product Quality Reviews, Stability etc, for products imported & marketed.● Perform line quality tests.● Maintained professional inspection equipments, evaluated production processes increase overall efficiency, & created monthly reports.● Co-ordinate Product release in Compliance with GMP & Company SOPs.● Provides final review & approval of Corrective Action & preventive Actions(CAPA), Deviations, Change control as per GMP procedures, protocols, forms & instructions.● Inspected Production area assisted in the development of products & collaborated with colleagues from other departments.● Review Complaints/recalls & perform Root Cause Analysis & provide Final Report.● Perform Internal Auditing & External Auditing including participating in client audits, Health Canada Audits.

QUALITY DOCUMENTATION SPECIALIST•Prepared and Reviewed Of standard operating procedure (SOP's), Oversight Observation Compliance, Site Master File (SMF), Batch manufacturing records (BMR), Logbooks and also Revised SOPs, reviewed batch records.• Maintained periodically validation for analytical instruments• Performed Gap Analysis for the Department and found the critical point to the production department and Followed up for compliance.• Verification and approval of all certificates of analysis by comparing to product specifications (COA) to release product in time• Prepare complaint investigation reports and work closely with others on site events to verify scope of investigations, assure root cause analysis and batch impact assessment are adequate, and recommend corrective actions to prevent deviation recurrence; ensure on time closure.Conducted internal GMP audits and Performed• Management Review• Provide training on new development and QA analysts on various analytical techniques, compliance of safety requirements, drive analytical laboratory compliance with CGMP/GLP and ICH/FDA guidance's Filed and maintained batch records Performance.PROCESS QUALITY ASSURANCE SPECIALIST•Responsible for identifying deviations and change control in the processes that ensure all activities are cGMP compliant, identifying corrective actions, assisting with RCA• Reduce inefficiencies by tracking and evaluating non-conformances that occur during the manufacturing process• Ensure compliance with SOPs, Policies and Procedures as required by company and regulatory agencies Lead and participate in site quality and process improvement initiatives.• Track OOS & OOT documentation.• Perform Manufacturing In-process QA inspection• Track wise Evaluates Corrective Action/Preventative Action (CAPA) effectiveness.• Perform final QA review and provide final disposition for investigations, deviations andСАРА.• Audits faced: USFDA, local regional audits, internal QA audits.