Charles Rajkumar Amburose

• Maintain data integrity and ensure compliance with company SOPs and study protocols, QMS, and GCP regulations.
• Serve as point of contact for management as a Quality representative to ensure the day -today site Quality aspects, audit plan, execution and deliverables.
• Oversee the compliance with legal, regulatory guidelines such as ICH-GCP, New drug clinical trial rules, principal of GLPs and other applicable quality standards.
• Serve as a mentor to other Quality team members, provide training and work direction as required.
• Ensure the effective implementation of independent Quality Assurance activities throughout facility and clinical projects.
• Perform review of calibration, validation data including computerized systems as per GAMP 5 requirements.
• Perform the internal audit, third party audit (i.e. Vendor qualification and re-Qualification) audit to ensure the compliance the organization requirements.
• Investigate the deviations, performed root -cause analysis and verification of CAPA and manage the effective change control procedures.
• write the department SOPs and review the operational SOP in quality and regulatory aspects.
• Face the sponsor and regulatory audit/Inspection and provide the CAPA within timeline.
• Participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings, improve quality and provide quality inputs to new projects.
• Analyzed quality management system metrics to identify trends, lead improvement projects and prepare third-party inspections and audits.

- Manage Quality Assurance department functions to assure that all the processes, procedures and activities are in compliance with ICH GCP, GLP and other prevailing regulations and guidance.

- Responsible for plan, conduct and/or overseeing audits of internal procedures, SOPs, clinical sites, clinical study reports, clinical trial master files, clinical databases, contract research organizations, clinical investigators, contract labs, and outside vendors.

- To host sponsor’s audits, third party audits and regulatory body inspections/auditors.

- Prepare and assist in preparing annual reports and quality trending reports.

- Evaluate quality events, incidents, queries, and complaints and all related quality legislation and compliance issues

- Ensure regulatory guidelines are communicated through corporate policies and procedures.

- Utilize guidance documents, international standards, or consensus standards and interpret for guidance.

- Ensure that investigator, vendor, facility and system audits are conducted.

- Communicate any critical compliance risks noted from these activities to senior management.

- Review the qualification and validation documents pertaining to the computerized system. Audit relevant computerized system during study audits and system audits.

- Analyse the root-cause for non-compliance / deviations; analyse trends observed (if any) and advice on resolving issues.

- Qualification and validation review of equipment’s.

- Review and approval of Change Control.

- Participate in Regulatory inspections/ Sponsor audits and prepare and review corrective and preventive action plan and follow-up on the implementation of the same.

- Prepare and review corrective and preventive action plan and follow-up on the implementation of the same.

- Manage Quality Assurance department functions to assure that all the processes, procedures and activities are in compliance with ICH GCP, GLP and other prevailing regulations and guidance.

- Responsible for conduct and/or overseeing audits of internal procedures, SOPs, clinical sites, clinical study reports, clinical trial master files, clinical databases, contract research organizations, clinical investigators, contract labs, and outside vendors.

- To host sponsor’s audits, third party audits and regulatory body inspections/auditors.

- Develops and enhances quality processes to promote, facilitate and ensure compliance with all regulatory and company standards.

- Providing training to process team and identifying the gap analysis and initiating CAPA Plan and ensuring that CAPA is effective in place consistently.

- Managing and Controlling Quality Management System, SOP, Quality Manual, Safety manual, Training Records and archival management.

- Management of the Deviations, Change Control Procedure and Assess the trend analysis. Submitting the Quarterly Report to the HOD-QA /Management for action.

- Interacting with Investigators/Personnel and initiating new system and procedure and Root Cause Analysis and CAPA of the observations/Findings issued by QA, External Auditors and Regulatory inspectors.

- Responsible for ensuring and reviewing of Protocol, ICD, and TMF, CRFs, Study raw data and clinical study Reports (CDISC and SDTM requirements), PK and Statistics analysis data in compliance to the protocol, SOP, ICH E6, ICH E3 and Regulatory guidelines for BA/BE studies.

- Instrumental in organization and oversight of 21 CRF Part 11 compliance and computer system validation (IQ/OQ).

- Successfully implementation of Automation system in organization such as sample storage, sample pipetting system, BMI, Volunteer management system.

- Qualification/surveillance of Vendor/Site audits such as Clinical laboratory, IEC and Calibration agency and Archival facility, catering services etc.

- Plan, Oversee QA infrastructure, Recruitment and Administrative process.

- Supervising quality assurance functions, training of staff, and interacting with investigators, clients and internal group.

- Managing the writing, revising and reviewing of all Standard Operating Procedures.

- Assisting/Responds to Regulatory and sponsor queries / comments in timely manner.

- Providing training and guidance to staff regarding compliance and interpretation of regulations.

- Handling external audits conducted by regulatory bodies/Sponsors and correcting the non-conformities.

- Report of deviations from protocol or other relevant standards, SOPs and reporting them to management.

- Preparing audit plan for internal as well as external audits.

- Responsible to delegation of study to personal and time management.

- Supervising quality assurance functions, training of staff, and interacting with investigators, clients and interval group.

- Managing the writing, revising and reviewing of all Standard Operating Procedures Assisting/Responds to Regulatory and sponsor queries / comments in timely.

- Providing training and guidance to staff regarding compliance and interpretation of regulations.

- Handling external audits conducted by regulatory bodies/Sponsors and correcting the non conformities.

- Report of deviations from protocol or other relevant standards, SOPs and reporting them to management.

- Responsible for audit for SOP, Quality Manual, Protocols, Case report forms (CRF), Informed consent documents (ICF), Raw Data and other study as well as system related documents.

- Reviewing of clinical report. Conducting internal/external audits. Co-ordination with Sponsor/clients audits.

- Providing training to staffs and communicating with internal departments.

- Ensuring that deviations are filled properly as per SOP/Protocol.

- Maintenance of training records and Calibrations record. Responsible for Archive facility

- Responsible for audit for SOP, Quality Manual, Protocols, Case report forms (CRF), Informed consent documents (ICF), Raw Data and other study as well as system related documents.

- Reviewing of clinical report. Conducting internal/external audits. Co-ordination with Sponsor/clients audits.

- Providing training to staffs and communicating with internal departments.

- Ensuring that deviations are filled properly as per SOP/Protocol. - Maintenance of training records and Calibrations record.