Sumedh Darokar Email & Phone Number

Hello, I’m Sumedh, Looking for an opportunity in Development Quality Assurance department.I am a development QA executive with 1 year & 3 months of experience. I have a proven track record of meeting & implementing Quality systems in R&D (Analytical & Formulation) by creating effective strategies that align with company goals.I have formulations solid oral exposure.I am skilled at reviewing and handling critical quality system documents such as change control, deviations, incidents, and Standard Operating Procedures (SOPs) & Conduct thorough reviews of analytical method validation, method verification, stability protocols, pharmaceutical development reports, master formula cards, specifications, and standard test procedures to ensure accuracy and reliability.As a results-driven individual with excellent communication skills, I am always learning and staying up-to-date with the latest industry trends and regulatory practices.If you are looking for skilled and experienced quality assurance executive/officer to help your organization, please feel free to get in touch with me.

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  Executive Development Qa

  Airis Pharma Private Limited

  Apr 2023 - Present - Hyderabad, Telangana, India

  Development Quality Assurance ExecutiveAs a dedicated Development Quality Assurance Executive in the pharmaceutical industry, I ensure the highest standards of quality and compliance in our research and development processes. My key responsibilities include:Quality System Documentation: Responsible for the preparation and review of critical quality system documents such as change control, deviations, incidents, and Standard Operating Procedures (SOPs).Analytical Review: Conduct thorough reviews of analytical method validation, method verification, and stability protocols to ensure accuracy and reliability.Vendor Management: Oversee vendor qualification processes and perform comprehensive vendor audits to maintain quality and compliance.Training & Development: Conduct internal training sessions and assist in external training programs to ensure personnel are well-equipped with the latest quality standards and practices.Internal Audits: Lead internal audits to identify areas for improvement and ensure adherence to regulatory requirements.Document Management: Manage the issuance, retrieval, and archival of essential documents to ensure proper documentation and compliance.Pharmaceutical Development Review: Review of Pharmaceutical Development Reports (PDR), Master Formula Card (MFC), specifications, and standard test procedures to ensure the highest quality and accuracy.