Pankti Visakh

Project 1: GxP-Compliant Project Management (Apr 2024 – Present)

• Led validation of a mission-critical web and mobile application for clinical trial label printing, ensuring full compliance with GAMP 5 and 21 CFR Part 11.
• Completed Operational Qualification (OQ) and Performance Qualification (PQ) within 82 days, despite evolving requirements, lean team size, and tight timelines.
• Derived and executed 500+ OQ/PQ test scenarios, achieving 100% test coverage mapped to functional specifications.
• Identified and resolved 66 critical defects, ensuring defect-free delivery and long-term system reliability.
• Developed a traceability matrix mapping FS to test cases, serving as a central validation artifact for audits and compliance reviews.
• Achieved 30–50% reduction in validation cycle time, 80–90% reduction in defect leakage costs, and delivered releases 2–4 weeks faster.
• Successfully managed client audits, providing robust documentation and evidence of compliance.
• Leveraged SimplifyQA platform to automate test execution, traceability, reporting, and compliance tracking, resulting in 40–60% manual effort reduction and 60–75% license cost savings.

Project 2: UAT Leadership – SimplifyQA ALM Tool

• Led a UAT team of 10 for the in-house ALM tool SimplifyQA, validating functionalities to ensure business alignment and compliance.
• Coordinated with stakeholders to define UAT scenarios, prioritize requirements, and align testing with business goals.
• Directed issue identification, documentation, and resolution, enhancing end-user experience and enabling successful product delivery.
• Established standardized testing guidelines, driving consistency and efficiency across multiple service projects.
• Conducted quarterly audits to evaluate process adherence, identify improvements, and uphold high quality and compliance standards.
• Fostered a culture of QA excellence, streamlining workflows and improving cross-functional collaboration.

Process Improvement & Operational Excellence

• Established and enforced quality control measures, reducing errors and rework significantly.
• Applied Lean Six Sigma methodologies to eliminate waste, enhance productivity, and improve overall performance.
• Championed change management initiatives, achieving successful adoption of new processes across teams.
• Led cross-functional process improvement projects, optimizing workflows and boosting operational efficiency.
• Managed complex, multi-stakeholder projects, consistently meeting timelines, budgets, and quality expectations.

SimplifyQA – Marketing & Training Initiatives

• Designed and deployed marketing collateral (brochures, campaigns, product videos), increasing product visibility and user engagement.
• Authored training tutorials and onboarding materials, accelerating adoption and improving knowledge retention.
• Created structured user assessment questionnaires, enabling alignment of product features with client needs.
• Collaborated with cross-functional teams to ensure marketing and training initiatives effectively communicated SimplifyQA’s value proposition.
• Advocated a user-centric approach in design and communication, driving successful product positioning and adoption.

Content Strategist / Technical Writer / Marketing Specialist

• Composed, curated, and maintained the company website content, driving a 25% increase in site traffic and improving lead conversion by 15% through engaging, SEO-friendly content.
• Introduced structured product documentation for the flagship SaaS solution, reducing client and subcontractor inquiries by 40%, thereby lowering support overhead.
• Authored 30+ articles on company achievements, founder stories, and product innovations, enhancing brand visibility and thought leadership in the industry.
• Collaborated with designers to create 20+ brochures, posters, videos, and infographics, boosting campaign engagement rates by 35%.
• Developed internal guides, whitepapers, FAQs, and instructional materials, improving onboarding efficiency by 30% and reducing training time for new hires.
• Produced user manuals, feature guides, release notes, and installation guides for multiple software releases, ensuring 100% compliance with documentation standards.
• Scripted and authored feature walkthrough videos, teasers, and launch content, contributing to a 20% increase in product adoption post-launch.
• Created and managed LinkedIn articles, posts, and ads, resulting in a 50% rise in social media engagement and stronger global brand presence.
• Partnered with sales and marketing teams to craft winning RFP responses, securing 3+ new enterprise clients and increasing revenue through international product sales.
• Analyzed market trends and shared insights with product and delivery teams, enabling data-driven decision-making that supported 10% faster go-to-market strategies.
• Built and nurtured client relationships, achieving 90% client satisfaction and contributing to repeat business growth.

• Company Overview: Healthcare software product development and services organization
• Developed and maintained life sciences products, ensuring compliance with GAMP (Good Automated Manufacturing Practice) guidelines.
• Successfully met all GxP (Good x Practice) requirements.
• Worked on the labeling of medicines for clinical trials, ensuring accuracy, regulatory compliance, and alignment with trial protocols.
• Implemented robust quality systems for product lifecycle management.
• Built a Proof of Concept for the External Online Label Approval
• Understand the designing of layouts, Partial Page Rendering and Coding
• Achieve the Internationalization functionality for several languages
• The POC was developed over the course of four months, with a lot of self-learning and hard work
• Created ADF libraries for the ADF skinning, Template, Login and Internationalization modules and deploy them as ADF Shared Libraries
• Designed layouts for Templates, Pages and Page Fragments
• Developed reports using the iText Library for PDF generation and presentation via inline frames and bounded task flows
• Generated the logs using the ADF Logger
• Implementation of including Manifest information of all Java Classes
• Oracle WebLogic R2 Server used for Deployment purposes
• Healthcare software product development and services organization
• Rewritten the entire Presentation layer of the Radio Frequency Scanner application from the existing UIX implementation to Apache myFaces Trinidad MVC architecture
• Coded quite a number of functional and technical enhancements
• Numerous functional and technical issues in the previous UIX code were fixed.
• Received the honorary SPOT awards.

• Quality Assurance Engineer – Healthcare Software (Pharma & Life Sciences domain)
• Conducted comprehensive validation of life sciences software products, ensuring 100% adherence to GAMP and GxP compliance standards across multiple projects.
• Performed rigorous label verification for medicines in clinical trials, reducing labeling errors by 30% and ensuring 100% regulatory compliance.
• Owned and delivered end-to-end testing of the largest product module (~40% of product scope), driving on-time delivery for 5+ major releases.
• Collaborated with product owners and cross-functional teams to resolve 95% of field-reported issues within SLA, improving customer satisfaction scores.
• Executed regression testing and optimized test cases, achieving 20% reduction in execution time while maintaining high coverage.
• Participated in internal and external audits by providing detailed compliance documentation, contributing to zero major non-conformities.
• Identified, tracked, and documented 300+ software bugs, ensuring timely fixes and improved product stability.
• Monitored debugging and integration issues, leading to 15% reduction in recurring defects by recommending preventive measures.
• Applied patches, executed scripts in Show Window environments, and validated fixes, reducing downtime by 25%.
• Reviewed requirements and design specifications, catching critical defects early in the SDLC, which cut rework effort by 20%.