Ashwini Kapu

Hey,  

🔍 Are you seeking a dedicated and skilled CSV (Computer System Validation) professional to enhance your team's capabilities? Look no further! I'm actively exploring new opportunities and eager to bring my expertise to your organization.

About Me: With a robust background in CSV spanning over [5 years], I have successfully navigated complex regulatory environments while ensuring adherence to quality standards. My experience encompasses creation, review, and approval of various documents including validation master plan, VP, VR, URS, SRS, FRA, PQ, test scripts review, UAT, TM, smart Controls, SAP, SAR, Periodic compliance review (PCR), Compliance Report (CR), VSR, periodic compliance review, CAPA, RCA, internal Audits, where I've effectively managed validation processes, executed protocols, and maintained documentation to guarantee compliance throughout SDLC with regulatory requirements.

🔹 What I Bring to the Table: ✅ Proficiency in creating and executing CSV protocols and documentation. ✅ Expertise in risk assessment, gap analysis, and remediation planning. ✅ Strong understanding of FDA regulations (including 21 CFR Part 11), GAMP guidelines, and industry best practices. ✅ Proven track record of collaborating cross-functionally to deliver projects on time and within budget. ✅ Commitment to continuous improvement and staying abreast of emerging technologies and regulatory updates. ✅Stakeholder and vendor management are areas of my interests as well

🔹 Let's Connect! I'm passionate about leveraging my skills to drive success in challenging environments. Whether you're looking for a hands-on CSV specialist, a team leader, or a consultant to streamline your validation processes, I'm ready to contribute my knowledge and expertise.

If you're interested in discussing how I can support your organization's CSV needs, please feel free to reach out here, or via LinkedIn message or email at ash06.reddy@gmail.com. Let's explore how we can collaborate for mutual success!

Thank you for considering my candidacy. I look forward to connecting with you soon.

Best regards, 

Ashwini