Vengadasami RajaRaman

Analytical Research & Development and Quality Control Chemist with 14 years of experience supporting ANDA method validation, stability studies, and GMP laboratory operations. Strong expertise in chromatographic method impurity profiling, method transfer, and troubleshooting across HPLC, UPLC, GC, and dissolution platforms. Proven success in ensuring regulatory compliance with ICH, cGMP, 21 CFR Part 11, ISO standards, and global regulatory expectations.

Adept at collaborating with R&D, QA, and Manufacturing to accelerate product development, optimize analytical performance, and maintain audit-ready laboratories. Recognized for technical leadership, problem-solving, and driving continuous improvement in analytical environments.

Pilot Plant R&D Chemist-III - Cipla Pharmaceuticals - Fall River, Massachusetts, USA

(2024-09)

• Preparation of analytical method validation protocols and reports in alignment with ICH Q2 (R1) and internal quality standards.
• Executed cleaning method validation to support pilot plant cleaning procedures and ensure compliance with regulatory residue-control requirements.
• Executed analytical method validation as per ICH Q2 (R1) guidelines for assay, dissolution, impurities, and stability-indicating methods.
• Led successful method transfers from R&D to QC for ANDA products.
• Supported pilot-scale development of inhalation products (MDI) by generating critical analytical data during scale-up, exhibit batch manufacturing, and process optimization.
• Collaborated with regulatory teams to ensure method validation reports met global submission requirements.
• Coordinated inter-laboratory reproducibility studies to confirm method robustness.
• Supported technology transfer of new products to commercial manufacturing sites.
• Ensured analytical methods met 21 CFR Part 11 and data integrity standards.
• Achieved zero deviations during analytical method validation audits.

Senior Chemist - Novitium pharma LLC - New Jersey, USA

(2022-10 - 2024-09)

• Managed analysis of accelerated, intermediate, and long-term stability samples under ICH Q1A guidelines.
• Created and reviewed Stability Summary Reports and supported submission dossiers.
• Participated in cross-functional quality councils to enhance compliance and risk mitigation strategies.
• Implemented trending systems for proactive stability behavior assessment.
• Conducted root cause analyses and implemented CAPAs for stability failures and deviations.
• Coordinated with QA and RA for annual product reviews and post-approval commitments.
• Ensured GMP traceability for all stability chambers and sample management logs.
• Executed analytical method validation as per ICH Q2 (R1) guidelines for assay, dissolution, impurities, and stability-indicating methods.

Analytical chemist-II - Teva Pharmaceuticals

(2016-05 - 2022-09)

• Managed analysis of accelerated, intermediate, and long-term stability samples under ICH Q1A guidelines.
• Led periodic internal audits, ensuring QC readiness for external regulatory inspections.
• Oversaw corrective and preventive actions (CAPA) following OOS, OOT, and deviation investigations.
• Reviewed analytical data for completeness, traceability, and integrity (ALCOA+ principles).
• Managed online documentation and real-time review systems to ensure transparency.
• Authored and revised SOPs, test methods, and COAs in compliance with current regulatory updates.
• Facilitated cross-departmental review meetings to close deviations promptly.
• Coordinated inspection responses for regulatory audits from FDA and Health Canada.
• Maintained compliance dashboards for tracking audit observations and CAPA implementation.
• Enhanced documentation accuracy by integrating electronic laboratory notebooks (ELN).
• Achieved continuous 'audit-ready' lab status with zero critical findings.

Analytical chemist - Par Formulation Pvt. Ltd

(2014-07 - 2016-04)

• Supervised analysts performing wet chemistry, HPLC, GC, and dissolution testing.
• Developed training plans for staff on analytical method validation, data integrity, and GMP practices.
• Implemented competency matrices for performance evaluation and skills development.
• Supported daily troubleshooting of instruments and analytical methods.
• Facilitated cross-functional meetings with manufacturing, QA, and R&D teams.
• Implemented daily review logs to enhance batch release timelines.
• Promoted teamwork and accountability through transparent task delegation.
• Improved lab productivity by balancing workload distribution and automating calculations.
• Recognized for mentoring junior chemists who later advanced to senior roles.

Analytical chemist - SGS Lss India Pvt Ltd

(2012-07 - 2014-05)

• Addressed and resolved client technical inquiries, analytical data reviews, and method validation summaries with precision and timeliness.
• Supported global regulatory submissions (ANDA, NDA) through data verification, compilation, and cross-functional coordination.
• Represented the QC department during external audits and regulatory meetings, ensuring transparent and compliant communication.
• Responded effectively to auditor and customer queries concerning analytical methods, test results, and investigation outcomes.
• Ensured all client deliverables were completed within established timelines while maintaining the highest quality standards.
• Provided comprehensive analytical justifications during new product launches and technology transfer phases.
• Led cross-functional meetings to troubleshoot analytical challenges and implement technical solutions.
• Established clear communication protocols for client feedback and continuous laboratory improvement.

Master of Science - General Chemistry - Prist University

Bachelor of Science - General Chemistry - Bharathidhasan University