Jayaprakash Kallega

I am a seasoned IT leader with over 17 Years of experience in managing multi-disciplinary teams of varying sizes and complex programs of IT system implementation and operation, Data Integrity, Quality Assurance, Computer System Validation, Quality Assurance, Project Management, Business Process Analysis and re-engineering, Process Framework development, Risk Assessment and Profiling, Process re-Engineering, Reviews, Audits, GxP, Regulatory Compliance against FDA - 21 CFR Part 11 and GAMP 5.0 Framework in Pharmaceutical / Medical Device IT Compliance & Quality environment..

I have been accountable for successfully executing multiple technology projects, including support and maintenance releases, minor functional releases, and major products.

I have been accountable for targeted technology acquisitions as well as establishing strategic partnerships/supplier relationships.

I have rich experience in aligning business processes and systems with corporate strategy; ensuring overall IT infrastructure, landscape and roadmaps are integrated and supportive to business; leveraging cloud technology and service models to improve efficiency and reduce the total cost of ownership.

I have consulted globally for top pharmaceutical companies and advised in acquiring new systems, Computer System Validation, Project Management and Quality Assurance.

I also have broad experience with vendor selection process (RFP), setting up contractual agreements (MSA/SOW), on-premises and cloud-based software providers, identifying and developing high-quality startups and managed service providers for growth and strategic partnership.

I have rich experience in conducting and addressing audits, both internal and external

Lead IT-CSV function with direct management responsibility for all CSV activities and accountability for ensuring that the team has the technical and professional skills, organisational structure, capacity, and business processes in place

I have assured that budgets, schedules, and department performance requirements were met.

Oversaw, guided, and specified validation deliverables (e.g. Validation Plans, Validation Summaries, Supplier Quality Audits) to IT project teams that are developing, implementing, and supporting validated systems, or qualified infrastructure (inclusive of cloud-computing environments)

I have managed multiple projects concurrently and collaborated with key stakeholders and functional area customers across the Internal organisation (local and global) for process improvement initiatives

Provided leadership and direction to ensure documentation and testing practices meet applicable regulatory/data integrity requirements, company policies, and quality standards, using sound risk-based computer system validation and QA testing practices to reduce time to go-live.

Lead implementation of quality systems policies, procedures, and practices that pertain to IT compliance /computer systems validation and data integrity by managing cross-functional IT teams contributing to audit readiness.

Authored, revised, and performed maintenance and administration of departmental quality documents (i.e., policies, SOPs, WPDs, STLs, etc.) as necessary.

I Monitor new and emerging regulatory requirements and good practice guides for GxP computerised system, IT controls and compliance and keep abreast of the evolving regulatory policy and industry best practices.

I have represented IT Quality and cleared external regulatory audits when part of a pharmaceutical manufacturing organisation, including remediation process in case of observations.

I am experienced in Operational management, planning, and administration of internal and vendor audit program related to computer software providers and computer-related service providers. I have scheduled and performed audits, managed internal and external resources to perform audits, and reported the audit program's status to management, including trend reports of audit findings for senior management reviews.

I have lead and developed staff within the function to a high level of competency and performance; set clear and comprehensive expectations; demonstrated role model leadership; provided meaningful, timely feedback about performance. I have trained and coached staff to improve individual performance and business results continuously.

I have conducted and coordinated validation, compliance, and quality training as needed