Kajal Patel

• Leading Data Integrity project in terms of collaborating with external

vendor, internal business team, lab users, Drafting, Reviewing SDLC

validation documents.

• Supporting laboratory operations in a manufacturing commercialization

department.

• Developed Computer Systems Validation CSV Master Plan to author, review

and approve CSV deliverables for systems as per GxP GLP, GCP, GMP, GDP, cGMP FDA Assessment.

• Authoring, executing, and reviewing CSV documents like Validation protocols, Acceptance testing, requirement and configuration specifications, requirement traceability matrix, Quality assurance Summary report, System documentation index for GMP analytical instruments and its software for liquid handler, cell analyzer, particle size analyzer, PCR systems.

• Working individually in drafting, reviewing decommission protocols and execution for GMP laboratory equipment.

• Training individual on decommissioning GMP laboratory equipment.

• Worked with internal and external stakeholders and team members on quality assurance efforts for Instrument hardware and Software components.

• Collaborated with external vendor and internal team on identifying instrument Gap Assessment for Data integrity remediation to meet part 21CFR 11.

• Work closely with project team leaders, Quality assurance leaders throughout the entire software development life cycle.

• Creating and maintaining Change Controls in Trackwise and Veeva change management system.

• Identified control gaps and deviations in processes, procedures and systems through assessment and performed Root cause analysis and CAPA for improvement.

• Driving corrective and preventive actions at leadership level to accomplish project closure and recurrence control, providing necessary resources, and clearing roadblocks.

• Work closely with regulatory groups to review technical content of the submissions.

• Working independently in investigation of process deviations, Change control, CAPA and non-compliance.

• Coordinate activities between Manufacturing Technology, Manufacturing Operation group, Supply Chain and Quality to meet project timelines.

• Designing and executing experimental studies for biologics drug products to support commercial manufacturing facilities.

• Performing Process Validation activities as required.

• Performing data analysis and monitoring for process performance and product quality.

• Working independently or in team to provide commercial manufacturing technical support, process monitoring, technology transfer and validation related activities.

• Matrix team leader accountable for commercial biologic product: including Drug product processes, regulatory filling, general inspections, investigation support and production monitoring.

• Performing manual or automated process performance data extraction, reporting and analysis.

• Managing and maintaining the newly renovated Laboratory to align with GLP/GMP requirements.

• Authoring Validation Master Plan and SOPs for GLP laboratory.

• Working independently or in team with analytical development team and MSAT group to conduct process characterization study, review process strategies on novel fill, filtration, sterilization, and single use disposable technologies.

• Participated in Root cause analysis exercises by using 5 why analysis and fish bone diagram tool at product manufacturing level for process and product improvements.

• Streamlined QA documentation by maintaining organized records of all inspections, tests, and findings.
• Performed detailed visual inspections of products, resulting in fewer defective units reaching customers.
• Ensured compliance with industry standards by diligently following inspection protocols.

• Prepare Audit Checklist and perform periodic audit to determine compliance with product specifications.

• Monitor and track open Incident Reports, Deviations and associated CAPAs for closure.

• Review cGMP Controlled Documents such as Master Batch Records for production, test methods, specifications, and ranges while managing implementation of required changes to meet GMP and internal standards.

• Assist with writing and review of Standard Operation Procedures as needed.

• Possess knowledge in working with SAP, SMAQ, LMS and Track wise ERP System.

• Manage to appropriately escalate compliance issues.

• Communicate audit results to management through written audit reports.

• Manage post-audit activities and follow-up on any necessary corrective and preventive actions.

• Review and issue manufacturing and packaging batch record for accuracy prior to production.

• Check and approve manufacturing equipment and rooms for cleanliness being used for manufacturing & packaging department.

• Review technical documents like user guides, data sheets, develop, execute & write commissioning and validation protocols (IQ, OQ and PQ).

• Participate in Process Validation and Qualification of manufacturing equipment.

• Identify, design, and execute continuous improvement activities to support manufacturing operations of commercial products such as oral solid, suspension, parenteral and semi-solid drug product and its technology transfer.

• Supported internal audits by providing necessary documentation and evidence of compliance with relevant regulations and standards.
• Reduced defect rates by closely monitoring production processes and promptly addressing any deviations.
• Collaborated with cross-functional teams to pinpoint root causes of defects and implement corrective actions.
• Examined products for imperfections and defects.

• Collaborated with cross-functional teams to ensure alignment on regulatory requirements and timelines.
• Supported regulatory compliance efforts through diligent adherence to industry best practices and guidelines for validation activities.

• Prepared and reviewed IQ, OQ and PQ protocols for tablet compression machine and mixing equipment.

• Developed and executed process validation and cleaning validation protocols for tablet manufacturing methods.

• Prepared validation master plan and validation summary and test method summary reports.

• Evaluated potential process weaknesses and failures by reviewing the FMEA for manufacturing process.

• Planned, conducted, and testing of raw material and finished product to ensure that specifications are met to comply with GMP.

• Inspected production line, process, and operation periodically and check on the implementation of Standard Operating Procedures (SOP) during the Production operation.

• Investigated and reviewed customer complaints and non-conformance issues to resolve quality problems and improve quality standard to meet customer's requirements.

• Ensuring GMP and regulatory compliance during the manufacturing, packaging, testing & distribution by conducting internal audits, documentation reviews and continuous follow ups to meet 21 CFR part 210/211.

• Managed and supported quality management system and its documentation for continuous improvements.

• Regularly audited project procedures, training, documentation, and records reviewed process deviations and tracked CAPA & monitoring the effectiveness of CAPA.

• Prepared and reviewed SOPs, production batch record, and Master batch records before releasing finished batch for distribution.

• Monitored and adjusted on-going production process, proper supply of material and equipment operation to ensure quality and productivity.

• Supported in SOPs writing, CAPA, OOS Investigation, root cause analysis.

• Performed validation and calibration of equipment as per written SOPs.