Akansha Pal

● Authored validation reports and designed, implemented, and validated 21 CFR Part 11 compliance strategies for Labware LIMS.

● Work collaboratively with Quality Management (QMS) to support improving computer system validation processes and practices.

● CSV activities throughout SDLC/SLC with compliance to 21 CFR part 11, EU annex 11 and other regulations.

● CSV Project Management including resource, accounts, pre-sales support, Business risk assessments, Contingency planning.

● Risk Assessment, Testing, GAP assessment, Investigations.

● Used Track wise software to manage document relisted changes.

● Created test batch and automated test execution scripts using Quality Center.

● Investigated and troubleshoot problems which occur and determine solutions or recommendations for mitigation and/or improvements.

● Assisted in the development of the Installation, Operational and Performance Qualification Protocols for the LabWare® Laboratory Information Management System (LIMS).

● Designed and developed test plans, centralized the management of the project, defect reporting and assigning the defects to the developers using QTEST, HP ALM and JIRA and provided support to quality processes (non-conformance, CAPA, change management, field events, audits).

● Participated in project teams and author (as applicable), review and approve computer validation related documentation including but not limited to risk assessments, validation plan, user requirements, specifications, UAT, traceability matrix, testing (FAT, SAT, IQ, OQ/PQ), data migration, QTEST, qualification/validation protocols and reports.

● Used SharePoint as defect tracking tool, uploading/retrieving documents, assigning tasks/resources, etc.

● Experience in developing and reviewing User Requirement Specifications (URS), Design Specifications (DS), Validation Protocols (IQ, OQ and PQ) and Document Change Request forms (DCRs).

● Worked on developing IQ, OQ and PQs protocols and reports for the following equipment: Incubators, Refrigerators, Cold-rooms, Autoclave, HPLC, Moisture Analyzer, XRD, XRF, FTIR, Reactor system, filter dryer system, laminar flow hood, Biosafety cabinet, Glass Washer, MilliQ Water systems, TOC Analyzer, Particle Counter, Fourier Transform Infrared spectroscopy and Particle size analyzer.

● Involved in authoring and executing temperature mapping protocols for Refrigerators, incubators, Freezers, bioreactors using Templates and Val probes.

● Developed Clean-in-place (CIP)/ Sterilization-in-place (SIP) cycle development, spray coverage testing, sample testing and parameter calculation for CIP skid, TFF skid, spray dryer, tanks and isolators.

● Performed temperature mapping, thermocouple calibration, sterilization, heat distribution, penetration, three biological indicator studies for various process equipment’s.

● Generated a cleaning validation procedures and site cleaning validation program

● Prepared equipment/utility systems for qualification studies and executed according to approved protocols and SOPs.

● Authoring and executing procedures, IO and PQs of equipment like autoclave and other CTU’s.

● Involved in writing and execution of IQ and OQ protocols for Liquid borne particle counters, centrifuges, HPLC, GC, UV-Vis, and Balances.

● Executed Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) for Refrigerator, freezer, walk in cold room, incubator, and autoclave.

● Performed temperature mapping, thermocouple calibration, sterilization, heat distribution, penetration, three biological indicator studies for various process equipment.

● Assisted in Performing Risk Assessment using the GAP Analysis and GAMP guidelines.

● Periodic Assessment Review of equipment and systems.

● Reviewed engineering drawings (P&IDs), equipment and component drawings for refrigerator and freezers and Utilities.

● Developed final reports summarizing qualification and commissioning work.

· Presided over a team of fellow students, assigned with scoping the necessary regulatory inputs to International regulatory strategy and its execution, and providing proactive regulatory intelligence

· Successfully identified and documented existing bridging rights/expedited approval regulations, based on prior marketing approval

· Investigated the many reimbursement possibilities for digital therapeutics

· Identify the methods for quick and effective application for digital therapeutics

· Spotlighted the apps that are now commercially available and their pathways for the device's release and successful market entry

· Supported by commercially available examples of pre-existing data from various digital therapies

· Served as a liaison between the sponsors and the project team, cross functional and coordinating with project timelines, providing weekly status updates, adhering to, and executing the communication with strategic planning

• Prepared and submitted regulatory file applications and supporting documentation.
• Interpreted regulatory rules or rule changes and communicated with others through corporate policies and procedures.

• Interpreted analytical data, converting to technical documentation for use in training manuals and standard operating procedures.
• Maintained complete, accurate and legible test records, reviewing data for accuracy and trends and communicating concerns to supervisor.
• Input data into spreadsheets or electronic databases to build complete documentation of testing and troubleshooting procedures.
• Performed routine maintenance and calibration on testing equipment.
• Recorded and organized test data for report generation and analysis.
• Created testing protocols to be used across product lines.
• Reviewed and validated quality requirements for manufacturing planning, supplier purchase orders, and engineering specifications to meet contract compliance regulations.

· Ensured updating and maintenance of Batch Manufacturing Records and Quality Control testing protocols for raw materials, packaging materials, in-process testing, APIs, stability testing

· Examination of all in-process materials, packaging materials, labeling, raw materials, excipients, drug product containers, closures, and in-process materials

· Implemented in-process quality control & quality assurance (IPQC & IPQA) operations for tablet and capsules filling, sealing, and packaging line.

· Testing of process improvement characterization samples, Participating in internal audit

· Ensured company’s process compliance with GxPs (cGMP, GDP) and learned data error detection and correction.

· Performed Quality testing & inspections for raw materials, packaging components and labels in compliance with regulation

• Acquired knowledge of industry trends and developed solutions and strategy through effective research.
• Assisted in assembling project documentation for project manager, confirming inclusion of data and preliminary information.
• Audited incoming data points, collating information into useable planning packages for project management personnel.
• Managed client communication distribution during ongoing projects.
• Collaborated with senior leaders to create job bids for new projects.
• Tracked and recorded open and closed orders and change requests to prevent errors, keeping all team members aligned with current demands.
• Maintained open communication by presenting regular updates on project status to customers.