Sushruth Kaparthi
Senior Learning Consultant @ Novartis | Computer Systems Validation Expert, Ensuring Compliance with Regulations
- Role
- Senior Learning Consultant at Novartis
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Sushruth Kaparthi
Dynamic Senior Learning Consultant with over 11 years of experience in IT and a proven…
Experience
Senior Learning Consultant
Oct 2020 — Present · Hyderabad, IN
Key Competencies & Achievements:• Regulatory Expertise: Proficient in meeting 21 CFR Part 11 and EU Annex 11 requirements, ensuring compliance with global regulatory standards.• Change Control Support: Gather key information to assess change impacts, ensuring seamless application release management.• Documentation & Testing: Author, review, and refine SDLC documentation while facilitating user testing and validation.• Process Standardization: Govern policies, SOPs, and supporting materials to ensure cohesive integration with IT workflows.• Strategic Reporting: Operate within a matrixed structure, liaising with functional and project managers to drive transparency and alignment.• P&O Collaboration: Facilitated workshops, gathered requirements, and created risk-evaluated project plans to align IT solutions with organizational goals.• Cross-Functional Leadership: Collaborated with Product and Service Owners to deliver projects aligned with commitments while addressing critical issues.• Training Coordination: Coordinated training programs to help users effectively utilize existing systems, enhancing adoption and efficiency.• Technology Evaluation: Evaluated organizational technology use and needs, recommending improvements to hardware and software to optimize efficiency.• Audit Readiness: Supported audits and inspections by providing comprehensive documentation and expert assistance.• Deviation Management: Handled investigations, impact assessments, RCAs, and CAPA implementation to ensure quality system integrity.• LMS Administration: Managed LMS operations, including tracking, reporting, and delivering e-learning programs to enhance organizational learning.
Education
Sree Dattha Institute of Pharmacy
Masters of Pharmacy, pharmacy
2011 — 2013
KKECS college of Pharmacy
Bachelor's, Pharmacy
2006 — 2010
Tamil Nadu Open University (TNOU)
Master of Business Administration - MBA, Information Technology
Skills
- Strength
- Pharmaceutical Sales
- Clinical Pharmacology
- Pharmacovigilance
- Illustrator
- Pharmacology
- Intellectual Property
- Capability Building
- Hplc
- Pharmaceutical Industry
- Pharmaceuticals
- R&D
- Pharmaceutics
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