Anita Paliwal Email & Phone Number

Warwick, Rhode Island, United States

Reviewing the result of assay drug products, impurity, and degradation profiles for active bulk drugs (vendor evaluation), dissolution studies, author SOPs, and testing of R&D raw material samples. • Accountable for work on change control, GMP Investigations, and CAPA, OOS, and OOT investigations and ensuring appropriate CAPA actions are identified.• Examine and monitor the stability testing of clinical and experimental formulations, primarily using GC/MS, Headspace GC FID, and HPLC. Examine and analyze test results promptly; uphold GMP, ISO 9001, and safety regulations; create SOPs; and examine procedure studies, assay drug products, and corporate rules. • Promptly assess and examine test results and uphold corporate rules and procedures, safety, GMP, GLP, and ISO 9001 criteria.• Reviewing and approving SOPs and other quality-related documents.• Document audit findings and quality issues and report them to relevant stakeholders.• Performing internal and external audits to verify compliance with regulations.• Identify improvement areas in the quality assurance process and implement corrective actions

Pleasanton, California, United States

Managed GLP studies assessing the safety and efficacy of cleaning products and chemicals, ensuring data validity/reliability for regulatory evaluation and EPA approval. Served as point of contact for compliance activities and collaborated with scientists/technicians from various departments• Acted as the single point of control for the study, ensuring its scientific conduct and compliance with GLP Regulations• Led quality improvement team that reduced study revisions and new product development registration time by 25%.• Oversaw diverse teams of up to 10 in the design and execution of GLP projects for microbiology study, toxicology study, physical chemistry study, and storage stability and corrosion characteristics (SS&CC); preliminary studies for new products studies or amendment studies for EPA registrations.• Developed and wrote the study protocol with other scientists and quality assurance personnel.• Prepared batches with appropriate documentation and tracking, tested for quality and collaborated cross-functionally to generate accurate GLP data for business-critical EPA submissions.• Maintained comprehensive project documentation, including the project plan, protocol, analytical testing reports, audit findings, corrective action reports, amendments, deviations, final reports, and archived project after completion. • Maintained effective communication with the sponsor, test facility management, and other stakeholders.

Fremont, Ca

Analyzed and reported on ultrapure water (UPW) samples, rings, coupons, and wafer samples for semiconductor industry. Tested for total organic carbon (TOC), silica, and laser particle size using ion chromatography (IC) instrument, bacteria microscope, scanning electron microscope (SEM), and more.• Evaluated, interpreted, and verified analytical data, sending regular reports to clients using LIMS.• Assisted customers with developing new analytical methods to improve product and service offerings.• Provided technical training to laboratory technicians and other chemists.• Adhered to strict ISO 9001/17825 regulations and GMP/GLP guidelines, including addressing any audit findings.• Served as Be, Act, Engage Champion; member of safety and employee engagement committees; and on Air Liquide's Women's Initiative Network (ALWIN).

Milpitas, Ca

Analyzed drinking water and other samples for induced coupled plasma (ICP), mass spectrometry (ICP-MS), and ion chromatography (IC), drawing on knowledge of EPA testing methods.• Extracted and evaluated semi-volatile samples using gas chromatography instruments. • Participated in documentation of DOD, ELAP, and AIHA.• Adhered to company SOPs and practiced cGMP.

Calgary, Ab, Canada

Analyzed drinking water, sludge, and soil matrices, following EPA methods for nitrates/nitrites using IC instruments.• Managed water, soil, and drinking water sample analyses, including preparing parameters, handling data, and managing quality control.• Completed all associated paperwork, including calibration and run logs.• Handled instrument calibration, maintenance, and repair.• Participated in training of lab technicians.

Mississauga, On, Canada

Evaluated total Kjeldahl nitrogen, total phosphorus, and low total phosphorus in water and soil using Skalar instrument. Analyzed water, soil, and wastewater samples for alkalinity, pH, total organic carbon, turbidity, conductivity, chlorine, total suspended solids, and hardness.• Ensured proper disposal of waste in analytical laboratory.• Assisted in compiling, approving, and reporting data analyses using LIMS.• Analyzed quality control/client samples and standards to meet regulatory and client requirements.• Trained new employees on instrumentation, documentation, and data interpretation.

Master Of Science - Ms, Chemistry

Bachelor Of Science - Bs, Biology, General

Cpa (Prep), Finance, General

Relevant Coursework: Introductory Financial Accounting I and II • Management Accounting, Macro and Micro economics • Business Statistics •.

Hmx Fundamentals / Pro Online Certificate- Drug Discovery And Development

Hmx Fundamentals/ Pro Online Certificate Program- Clinical Drug Development