Neerati S Email and Phone Number

• Developed and updated Standard Operating Procedures (SOPs) to meet current GMP standards and maintain operational consistency.• Led laboratory investigations, including Laboratory Investigation Reports (LIRS), to identify and address root causes of deviations, ensuring data integrity.• Managed Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations, utilizing advanced analytical methods and regulatory expertise to uphold product quality.• Oversaw change control processes, ensuring all procedural updates were thoroughly evaluated, documented, and approved in line with regulatory standards.• Established and maintained Quality Systems in compliance with 21 CFR 211 and other global regulatory requirements.• Conducted comprehensive product complaint investigations, including root cause analysis and risk assessments, to determine and implement effective corrective and preventive actions (CAPA).• Implemented corrective and preventive actions to address FDA inspection findings, ensuring ongoing compliance.• Coordinated the collection, handling, and quality testing of product samples.• Managed reportable event investigations and collaborated with Third Party Manufacturers (TPMs) for sample returns and analysis.• Conducted CAPA investigations, driving the implementation of corrective and preventive actions to resolve recurring customer complaints.• Prepared detailed reports on investigation findings, contributing to continuous quality improvement initiatives within the QA department.• Utilized word processing software (e.g., MS Word) to create and revise documents such as SOPs, reports, and correspondence.• Participated in internal and external audits to ensure compliance with SOPs and regulatory requirements.• Collaborated with cross-functional teams to manage complaint escalation and resolution, ensuring prompt responses and customer satisfaction.

prepare and dispense medications prescribed by healthcare providers, ensuring the correct dosage and formulation.monitor for adverse drug reactions and drug interactions, ensuring patient safety.provide information to patients about their medications, including how to take them, potential side effects, and interactions with other drugs.