Phanindra Pakalapati

• Provide technical testing expertise to an Agile development team to be a trusted team member, to refine the product backlog, to ensure the quality and reliability of all functional components used by Icon Clinical Research to deliver clinical research services and to ensure that all systems meet customer requirements in a manner that is consistent with applicable regulatory requirements especially with regard to validation processes outlined in Good Clinical Practice and Good Manufacturing Practice and maintaining Separation of Duties
• Review and approval of process validation studies and analytical test method protocols and summary reports
• Review and approval of protocols and summary reports for qualification and validation of systems and facility, utility, laboratory and manufacturing equipment, and process controls system
• Primary point of contact for customer audits and regulatory inspections
• Championed the development and implementation of a certification program to ensure adequate investigations in support of a risk-based approach to corrective and preventative actions
• Championed the development and implementation of the cleaning validation master plan resulting in decreased risk of product cross contamination
• Responsible for development and implementation of QA programs, policies, and procedures to ensure GMP compliance of commercial and clinical trial material
• Development and implementation of audit schedules, auditors, and audit processes on behalf of QA
• Championed the restructuring of the current audit program to include procedures and work instructions for a consistent GxP risk-based approach
• Collaboration and expansion of the inspection readiness program, including support for foreign inspections
• Participate in the development of Master Control User Requirements, workflow development and development testing for document management application.
• Maintained up-to-date documentation of all test plans, procedures, results, and defect tracking databases for future reference or audits.

• Provided QA oversite for QC (review/approved test records, SOP's, C of A's Deviations, CAPA's, protocol and reports related to QC process standards in providing the QC team with QA guidance and decisions
• Project support as a quality specialist, final inspection, certification, and packaging of medical devices with all required documentation for further distribution at other location using SAP database, AS 400 quality system
• Supporting quality Manager reviewing quality documentation MDR, creating deviation reports and inspection of casting of medical devices, reading blueprints, using different gages as per inspection guide requirements
• Responsible for casting the Medical Device Products, and investigate root causes and customer complaints, and CAPAs to track investigations
• Worked on SOP and cGMP as per FDA requirements for medical devices and follows as per agreements approved by client needs approved casting of medical devices, verify accuracy all manufacturing procedure such stoning, glazing, penetration, etching, snag, x-ray reading, all other procedures
• Surgical disposables, FDA QSR, 21 CFR Part 820- Quality System regulation, ISO 13485 / ISO 14971, 60601-1 and deep understanding of medical devices classifications (Regional and International regulations)
• Knowledge of CFR part 211 and part 210 and computerized validation system, electronics signature update for technology requirements using Adobe acrobat reader.
• Maintained up-to-date documentation of all test plans, procedures, results, and defect tracking databases for future reference or audits.

• Provide technical testing expertise to an Agile development team to be a trusted team member, to refine the product backlog, to ensure the quality and reliability of all functional components used by BioTel Research to deliver clinical research services and to ensure that all systems meet customer requirements in a manner that is consistent with applicable regulatory requirements especially with regard to validation processes outlined in Good Clinical Practice and Good Manufacturing Practice and maintaining Separation of Duties
• Review and approval of process validation studies and analytical test method protocols and summary reports
• Review and approval of protocols and summary reports for qualification and validation of systems and facility, utility, laboratory and manufacturing equipment, and process controls system
• Primary point of contact for customer audits and regulatory inspections
• Championed the development and implementation of a certification program to ensure adequate investigations in support of a risk-based approach to corrective and preventative actions
• Championed the development and implementation of the cleaning validation master plan resulting in decreased risk of product cross contamination
• Responsible for development and implementation of QA programs, policies, and procedures to ensure GMP compliance of commercial and clinical trial material
• Development and implementation of audit schedules, auditors, and audit processes on behalf of QA
• Championed the restructuring of the current audit program to include procedures and work instructions for a consistent GxP risk-based approach
• Collaboration and expansion of the inspection readiness program, including support for foreign inspections
• Participate in the development of Master Control User Requirements, workflow development and development testing for document management application.
• Tracked test reports and failures determined by root cause data trends.
• Collaborated with development teams to identify, reproduce, and resolve software issues promptly.

• Coordinated studies of facilities, equipment, and processes to maintain validated state
• Partnered with contractors, engineers, laboratories, regulatory group, and other constituencies to maintain validation for aseptic filling, freeze-drying, and packaging operations
• Review and approval of validation packages, including protocol, execution package, final reports, and any exceptions
• Performed equipment audits, including autoclaves, freeze dryers and steam generators
• Managed successful installation and validation of new packaging vision system and packaging equipment for custom secondary packaging
• Review and approve IQ, OQ and PQ protocols for equipment such as ultra-low freezers, lyophilizes, incubators, heat sealers, etc
• Review validation protocols and ensure that it is executed within FDA compliance
• Review calibration certificates and ensure that it meets ISO 17025 standard
• Review PM Documents performed by contractors
• Ensure that the equipment meets the User Requirements
• Review change management system and approve changes to a qualified/validated system
• Identify the requirements to maintain the system in a qualified/validated state after the changes
• Review FAT performed on Manufacturing Equipment
• Work with Engineering Services and Manufacturing department to ensure compliance with CGTP guidelines and AATB standards
• Work with cross-functional departments on identifying the right piece of equipment to having it qualified for use
• Review CAPA's, OOT results, deviations and perform investigations and provide viable solutions, Perform Internal Audits
• Assist Engineering Services in writing validation protocols and identifying contractors for calibration and qualification.
• Conducted regular audits of QA/validation processes, maintaining thorough records for regulatory inspections as needed.

Master’s in Industrial Engineering from Wichita State University, Kansas.