Chintal Desai

• Maintain all appropriate quality related documentation, as assigned while ensuring adherence to, and compliance with, established company quality policies, SOPs and cGMPs.
• Maintain knowledge of current regulatory requirements and standards pertaining to QA Documentation, Stability and APR, accordingly create/revise SOPs.
• Conduct investigations and identify appropriate CAPAs and CPIs to improve the systems and program.
• Manage Document Change Request (DCR) and Management of Change (MOC) process to ensure compliance and timely completion of the tasks.
• Ensure timely archival of GMP documents to QA Documentation Room and maintains the inventory and traceability of all archived documents; ensure all archived documents are readily available during agency inspections and other audits.
• Assure all Stability and APR program compliance with all cGMP, Food and Drug Administration (FDA), Drug Enforcement Agency (DEA), and Occupational Safety and Health Administration (OSHA) regulations, as well as all applicable company compliance guidelines, standards and objectives.
• Manage and oversee all aspects of stability program for submission batches and commercial products.
• Ensure APR schedule and timeline are followed to maintain program compliance; ensure collecting and compiling all relevant data for APR presentation, report summary, etc.
• Ensure timely communication with external partners on the changes and address all the queries related to their products.
• Develop and maintain tracking reports and other tools for monitoring Quality System.
• Participate in inspections and internal and external audits, as needed.
• Manage, coach and mentor direct reports.

• Projects include: New Product Launches, Alternate API/Excipient Qualification, Scale up/down, Process Validation/Qualification, Cleaning Validation, Equipment Qualification, Submission, Product Lifecycle Monitoring, Technical Transfers, Process Improvement, Container Closure Qualification, and other projects as necessary.
• Skilled in Writing and Reviewing:
 Process & Cleaning Validation, Submission, Monitoring, API/Excipient/Container Closure Qualification Protocols & Reports,
 SOPs, Official Forms & Memos,
 Investigation, Corrective and Preventative Actions (CAPA) & Planned Deviation Reports,
 Process Validation Plans & Process Flow Diagrams,
 Master Production /Packaging / Labeling Records,
 Change Controls/MOCs/Packet Initiation in Master Control,
 Validation Annual Reports,
 Risk Assessment Reports,
 Internal Audit Responses.
• Own Cleaning Validation/Verification/Monitoring Program. Projects include: Prepare, maintain and evaluate Cleaning Validation Matrix. Calculating Maximum Allowable Carryover (MAC) residue limits for Active Ingredients and Detergents. Develops Cleaning SOPs and cleaning recipes for processing and packaging equipment. Schedule and execute cleaning verification and monitoring activities.
• SME for electronic batch record (eBR) /Production Module in Master Control. Production Module implementation project includes:
 Master Template creations learning and configuration for two complete products (extended-release suspension and tablets manufacturing, packaging, and labeling).
 Designing the BPP, SOP, Configuration Roles related to eBR.
 Review current business process related to supply chain, manufacturing, packaging and Quality Operations to streamline the Production Module with ERP system and come up with User Requirement Specification (URS) to streamline/optimize the current manufacturing, packaging, quality operation and documentation processes.
 Integral part of internal and external (Master Control) teams discussion on designing the plan for implementation and/or planning required for integration points with ERP system per URS.
 Contributed to finalize the Management of Change process workflow for the eBR creation/update.
 Involved with mock trials to test the production module for the batch manufacturing.
• Recommend process improvement projects, aid in Manufacturing and Packaging process troubleshooting, problem solving and product impact analysis.
• Leadership role on TS projects by coordinating activities within and across departments, executing the projects, schedule project meetings, prepare meeting minutes, resolve conflict and meet the project deadline.

• Understanding the manufacturing process and designing the validation approach.
• Develop, design, write protocol, execute and analyze data for TOC Analytical Method Validation.
• Responsible for writing and reviewing Validation Protocols, Completion Reports, Deviations, SOPs according to 21CFR, ICH and GMP standards.
• MACO calculations for Active Ingredients and Detergents residual limits.
• Set up meetings and coordinate activities with cross functional teams; Microbiology & QA department.