K. Sandeep Kumar Reddy

Vendor Audits: Led domestic and overseas (China) vendor audits, including preparation of audit schedules, audit reports, and CAPA follow-ups. Ensured timely audit closures and adherence to compliance standards.

Quality Agreements: Maintained and managed Quality Agreements for key starting materials (KSM) and packaging material vendors, ensuring alignment with regulatory standards.

Change Proposal Management: Evaluated and approved change proposals from KSM/ADI vendors; coordinated with Regulatory Affairs team to ensure accurate updates for Drug Master File (DMF) amendments.

Contract Manufacturing Unit (CMU) Oversight: Responsible for the qualification and ongoing monitoring of contract manufacturing units, ensuring process alignment and regulatory compliance.

Technology Transfers & Process Development: Managed seamless technology transfers between R&D and manufacturing sites. Reviewed process development reports to ensure alignment with quality standards.

Validation & Compliance: Developed and reviewed Validation Master Plans, managed process validation, stability studies, and hold-time studies. Initiated and managed Cleaning Validation including CPV reports, PDE/ADE, and solubility data and continued monitoring of manufacturing processes.

Change Management & Deviation Handling: Oversaw change management processes, reviewed and addressed deviations, out-of-specifications (OOS), Out of Trends (OOT) and ensured regulatory compliance.

Annual Reports & Regulatory Support: Compiled and reviewed Annual Product Quality Reviews (APQR). Provided support for regulatory filings and deficiency responses.

Quality Management Systems: Prepared and reviewed SOPs, protocols, and documentation in line with regulatory and customer requirements. Ensured adherence to GMP, data integrity, and quality risk management principles.

Training & Self-Inspections: Conducted internal self-inspections, equipment qualifications, and training sessions to ensure compliance and quality best practices across the organization.

Regulatory Audits: Coordinated responses for major regulatory audits, including USFDA, EU GMP, MHRA, ANVISA, COFEPRIS, Health Canada, WHO, CDSCO, and ISO.

Process & Cleaning Validations: Initiated and executed process validations, stability studies, and cleaning validations to support regulatory and product quality requirements.

Line Clearance: Oversaw line clearance procedures to ensure proper cleanliness and readiness of equipment and manufacturing areas prior to product changeovers.

Equipment Hold Time Studies: Led Dirty Equipment Hold Time and Cleaned Equipment Hold Time studies to assess and ensure the integrity and quality of equipment during production and cleaning intervals.

Product Release & Documentation: Coordinated product release processes and prepared Annual Product Cleaning Review (APCR) reports. Developed and reviewed Annual Product Quality Reviews (APQR) and Continuous Process Verification (CPV) reports.

Statistical Analysis: Performed statistical trend analysis using Minitab to drive process improvements and ensure alignment with regulatory and quality standards.

Deviation & Compliance Management: Managed and resolved deviations through thorough investigations, root cause analysis, and implementation of corrective actions. Ensured compliance with GMP and data integrity regulations.

Audit & Regulatory Support: Supported and coordinated responses for customer and regulatory audits, including major audits from USFDA, EU GMP, WHO, CDSCO, and ISO, ensuring compliance and ongoing process improvements.

Vendor & Supplier Management: Managed key vendor relationships, ensuring adherence to quality and regulatory standards, and handling change management processes to support continuous improvement.

Product Release & Documentation: Led product release activities, ensuring compliance with regulatory and quality requirements. Prepared and reviewed Site Master Files, SOPs, forms, and annexures for accuracy and compliance.

Regulatory & Customer Support: Addressed customer and regulatory queries, providing support for customer and regulatory filing requirements. Ensured the company’s compliance with regulatory filing deadlines and guidelines.

Audit & Compliance Management: Coordinated internal audits, ensuring compliance with GMP and regulatory standards. Supported external audits, including USFDA, EU GMP, WHO, CDSCO, and ISO, to maintain certifications.

Deviation & Risk Management: Provided support in deviation management, including investigation, root cause analysis, and corrective action implementation. Assisted in the development and management of risk mitigation strategies.

Training & Documentation Control: Managed GMP and OJT training programs, ensuring all employees were up to date with quality standards. Oversaw the archival and retrieval of critical documents to ensure compliance with data integrity standards.

Quality & Regulatory Compliance: Ensured full compliance with GMP and regulatory requirements, driving improvements in quality systems, and maintaining data integrity in all processes.

Document Control & Issuance: Managed the issuance and review of essential documentation, including batch product records and analytical workbooks, ensuring accuracy and compliance across all cross-functional teams.

Plant Monitoring & In-Process Controls: Monitored critical control points during manufacturing and packaging processes to ensure compliance with GMP standards, ensuring product quality throughout production.

Vendor Management & Qualification: Prepared vendor qualification and requalification reports. Maintained approved vendor lists to ensure alignment with quality and regulatory requirements.

Training & Development: Coordinated GMP and OJT training schedules, ensuring timely and effective training for all employees to maintain high-quality standards and compliance.

Quality Trend Analysis: Compiled and analyzed raw material and packaging material quality trends to identify potential issues and areas for improvement in the supply chain.

GMP Compliance & Regulatory Audits: Ensured adherence to GMP standards and regulations. Supported customer and regulatory audits, including those from USFDA, CDSCO, and ISO, ensuring timely and effective audit responses.