Kapilrajbharat Gudala

Oversaw onboarding of new manufacturing sites, ensuring compliance with standards and protocols. Executed planning and governance meetings to align operations across Novartis manufacturing sites. Monitored KPIs to assess performance and drive continuous improvement initiatives. Conducted quality review meetings to uphold product integrity and regulatory compliance.

comprehensive ownership of quality technical agreements for suppliers and CMOs

Supported audit readiness and inspection processes, ensuring compliance with standards. Conducted supplier audits, addressing corrective actions and closure of findings. Managed audit records to maintain comprehensive documentation and compliance oversight.

stakeholder management across quality assurance, quality control, manufacturing, supply chain, procurement, regulatory, and legal.

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Review and approve quality agreements for CMOs and supplier specifications, supplier questionnaires, and risk assessment reports to ensure alignment of product quality attributes, testing strategies, stability requirements, and acceptance criteria with regulatory filings and internal quality standards, and archival in system.

accountable for delivering quality technical expertise and oversight for own manufacturing and cmos.

accountable for escalating identified deficiencies to stakeholders and mitigation plan and compliance.

spearheaded identification of proper GMP or non-GMP phase-appropriate documentation strategies

Spearheaded continuous process improvements to elevate efficiency, quality, and process harmonization while ensuring compliance with requirements.

responsible for developing, monitoring, and reporting metrics to senior leadership management to evaluate team performance health

preparation and review of quality system / QMS SOPs and conducting periodic gap assessments.

responsible for reviewing and approving annual product review reports, change controls, and CAPAs.

Responsible for planning and executing activities related to development quality assurance, monitoring exhibit batch manufacturing compliance.

spearheaded review and approval of executed batch

Maintained manufacturing and batch packing records for clinical trial batches. Ensured accurate documentation of bio batch processes. Monitored compliance with regulatory standards during batch production. Coordinated data entry for batch records to facilitate audits.

product development documentation risk evaluation qbd validation/qualification

protocols and documentation (facility utility equipment process analytical method stability cleaning validation and hold time analysis)

expertise in quality management systems (QMS) – analysis

implementation approval and compliance for change control incidents, out-of-specification market complaints, and corrective and preventive actions.

successfully assisted regulatory affairs team for ANDA/NDA submissions and regulatory deficiency resolution

qualification and regulatory compliance of external manufacturing facilities

cmo's/sbp/cros - scheduling execution report generation and closure.

qualification of vendors and suppliers and conducting risk assessment.

• Expertise in Quality Management System (QMS) – Investigation,

Implementation, approval and compliance for Change controls, Incidents, OOS, Market Complaints and CAPA.

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Responsible for preparation and execution of Vendor Audit schedule, Audit Check list and Audit Questionaries', Qualifications, review of Quality agreements, support to the internal & external audits, making QMS documents ready for audit

• Performed the review of elemental impurities ICH Q3D risk assessment

• Preparation and Review of Quality System / QMS SOPs and performing their GAP Assessment periodical.

• Regulatory support in dossier compilation, review of regulatory documents like Batch Manufacturing and packaging records, validation protocols for new product submission, routing of post approval commitments, co-ordinate with global regulatory teams for change implementations, preparation and review of stability protocols and regulatory compliance activities.

• Successfully supported the regulatory team for preparation of CTD Module.

• Responsible for tracking of Regulatory Commitments and their compliance check periodically, tracking of regulatory audit observations and compliance

• Handling of QMS- Change Management System includes Impact assessment, evaluation, review, regulatory notification, implementation and effectiveness check, regulatory notifications, gap assessment with the GMP procedures with regulatory requirements.

• Successfully completion of Annual Product Review and conducted a SIRC (site level incident reporting committee) meeting for critical complaints received and initiate a Field alert report by communicating with the cross functional teams and Global teams and change control assessment with Cross Functional teams as a part of Change Control Board (CCB) meetings.

• Profound knowledge on SAP, QMS-TRACKWISE, LIMS, MINITAB, TRAINING MANAGEMENT SYSTEMS and Six Sigma Tools.

• Execution of Regulatory commitments, providing support to regulatory team for dossier compilation, review of regulatory submitted documents (Quality).

• Provide support to regulatory variations submissions, annual reports, initiation of variations in global track wise system and their compliance.

• To provide support in revision of Testing Monographs, specifications, test procedures as per regulatory requirements and perform the gap assessment periodically for compendial updates and monograph revisions.

• To provide support in the licensing and renewal requirements.

• To perform Annual Product Review for Mylan Marketed products.

• To perform review and compilation of Analytical test results including stability data, escalations, protocols from Laboratory Information Management System (LIMS), control and capability analysis from LIMS

• Handling of QMS- Change Management System includes Impact assessment, evaluation, review, regulatory notification, implementation and effectiveness check, regulatory notifications, gap assessment with the GMP procedures with regulatory requirements.

• Involved in root cause analysis of the potentially critical complaints received to arrive at most probable root cause of the reported incident by using various scientific tools.

• Preparation and Review of Quality System / QMS SOPs and performing their GAP Assessment periodically.

• Involved in root cause analysis for Laboratory incidents includes OOS, OOT and other laboratory incidents

• Handling of Laboratory Information system and GLP