Tridev Sudhakar Email & Phone Number

• Highly versatile pharmaceutical sciences professional with broad based GxP experience in manufacturing equipment validation and Process Validation along with Computer System Validation, Laboratory Equipment Qualification, supporting both proprietary and generic pharmaceutical industries.• Superior knowledge of GAMP, GxP and ERES (21-CFR Part 11) regulation of Electronic Records, Electronic Signatures and Audit Trails. • Extensive working experience on Analytical instruments like HPLC, GC, GCMS, ICP-MS; including expertise in Qualifications & Calibrations of these analytical instruments.• Worked on HPLC, GC, UV-Vis’s spectrophotometer, and other analytical instruments to troubleshoot common/high-level hardware and software issues.• Good understanding of various life cycle methodologies Waterfall, GAMP V, and Agile models.• Strong knowledge of SDLC.• Authored, reviewed, and developed SOPs.• Strong experience working with and validating SaaS/PaaS applications.• Experienced in preparing Deviation reports when the test criteria did not meet the acceptance criteria. • Expertise knowledge in Documenting and Execution of Test scripts (IQ/OQ/PQ), developing deviation forms and initiating change controls. • Strong experience in implementing Veeva applications such as Quality Docs, QMS and Safety Docs. Managed change control process for quarterly releases and validation testing for Veeva RIM and HEOR applications.• Experienced in developing test protocols (IQ, OQ, PQ) and other validation deliverables (i.e., Validation protocols, URS, FRS, Risk Assessments, summary reports, RTM etc.)• Diversified experience as a Validation professional in the pharmaceutical industry, known for the ability to create and execute processes that positively affect the compliance results.• Good understanding and implementation of 21 CFR Part 11 rules including Electronic Records, Electronic Signatures and Audit Trials.• Expertise in performing complete evaluation and investigation activities, documenting results of these activities and initiating further non-conformance investigation.• In depth knowledge of GCP, GMP and GLP in pharmaceutical industry• Extensive knowledge and experience in Good Document Practices (GDP)• Competent in quality system and standard 21 CFR (part 11, 50, 58, 210, 211) and GAP Analysis. • Thorough experience with the SOFTWARE DEVELOPMENT LIFE CYCLE (SDLC) approaches and familiar with Software Methodologies like AGILE, Waterfall, Spiral, V-Model and Iterative in relation to development and testing.