Subba Rao Nimmagadda

Post-graduation in Pharmaceutical analysis and quality assurance with 7+ years of extensive experience in Formulation Analytical R&D/Analytical Lab Compliance/Analytical data Review/Documentation with distinction of steering improvement initiatives with focus on streamlining & managing operations with proactive planning, steering change etc. with consistent contribution to increased performance. Knowledge in handling Analytical instruments like the HPLC, UPLC, GC, IC, LCMS, GCMS, Kf colometer, PSD, LBPC, Osmometer, Viscometer, Dissolution Apparatus (USP-TYPE-I,II,IV) and use of this knowledge in application. Analytical Method Development and method validations for API, different types of dosage forms such as Oncology, Non oncology Parenterals, Tablets, Capsules (Hard & Soft), Complex injectables like peptides, liposomes, emulsions, Suspenssions and Ophthalmics. Strong understanding of 21 CFR Part 11 drug GXP requirements including electronic records, electronic signatures, system validation strategies and documentation. Working experience in FDA regulated environment and research laboratories with good understanding of cGxP (cGMP, cGDP, cGLP) standards and Risk based validation. Expertise in developing the validation protocols, executing tests, and construction of summary reports for IQs, OQs and PQs. Experienced in drafting new SOPs& training users on SOPs for various systems. Extensive experience in validation, verification and implementation of enterprise software solutions including but not limited to Empower, EZ Chrom and ChromeLeon. Excellent communication, writing and interpersonal skills and strong ability to perform as part individually and also as a part of team. Extensive Experience in working with PowerPoint, Word, and Excel. Excellent Coordination skills, Communication Skills and strong Technical Writing skills and a good team player.

Pharmacological evaluation of synthesized compounds. (Quinazolinone 4-Ones) Testing for various possible activities by biological methods. It is a broad range of study and includes analgesic and anti-inflammatory activities. Formulation and evaluation of Montelukast sodium and Acebrophylline tablets. Formulate the procedure for manufacturing the tablets and developed a stability indicating method for evaluation of tablets and analytical method validation.

• Involvement in Global Compliance Audits and other quality audits.
• Participated in Internal Audits and Health Authority Audits and audit remediation’s.
• Effective and timely review, approval and implementation of documents including SOPs, specifications, Qualification, validation and protocols & reports and stability protocols in compliance with cGMP norms and global standards.