Nirali Amin Email & Phone Number

Parsippany-Troy Hills, NJ, US

Ahmedabad, Gujarat, India

• Managed and coordinated the redaction of essential clinical documents and safety reports to comply with global regulations, including the EU Clinical Trial Regulation.
• Supported IT in implementing clinical trial disclosure solutions and assisted CT Results Specialists.
• Maintained compliance with SOPs and cGMP guidelines, ensuring safe equipment use by following Execute production and equipment manuals.
• Successfully managed external GCP clinical, and non- clinical suppliers and dealt with supply chain challenges related to knowledge transfer of FDA and EMA regulations specific to the biotechnology industry.
• Carefully checked for completeness and accuracy in all paperwork and procedures pertaining to the clinical research by ensuring distribution of study tools and documents.
• Assisted team members in achieving project objectives, offered tactics for effective project management and goal fulfillment, and fostered team support as needed.

Ahmedabad, Gujarat, India

• Ensured accurate dosage and proper administration, enhancing patient safety and treatment efficacy in a clinical trial.
• Assisted in ordering and stocking pharmaceuticals, optimizing inventory levels for efficient pharmacy operations and managing proper destruction of clinical supplies.
• Keep files current and organize to manage the workspace by collating and archiving clinical documents, assisting with eTMF quality control plan.
• Updated records with relevant information, monitored for potential drug interactions, and ensured accuracy for patient safety as a part of clinical trial.
• Offered comprehensive insights on medications to healthcare professionals and the public, aiding in informed decision-making.

Gandhinagar, Gujarat, India

• Managed quality control measures, SOPs, manuals, and executed Corrective Action Plans, resulting in a consistent 20% reduction in quality-related audit issues.
• Kept an eye on and upheld ICH-GCP compliance as well as relevant national, regional, and international laws.
• Conducted comprehensive sampling and testing for raw materials, intermediate stages, and final products by fulfilling proper labelling requirements.
• Proficient in laboratory methodologies (UV, HPLC, GLC, HPTLC) and adherence to ISO 9001 standards for precise sample analysis.
• Conducted advanced microbiological assays, evaluated and validated them, requiring strong analytical skills and a thorough understanding of microbiological principles.
• Ensured all testing, including special projects and protocol-based testing, was completed in a timely manner while adhering to local procedures and cGMP regulations.

Master'S Degree, Regulatory Affairs

Bachelor'S Degree, Pharmacy