Experience

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  Virchow Biotech Pvt Ltd - India

  • India
  • Airlines and Aviation
  • 300 - 400 Employee

  • Assistant Manager

    • Sep 2020 - Apr 2023

    •Conducting Analytical Testing: Perform a wide range of analytical tests using various techniques such as HPLC, dissolution, wet chemistry and other relevant analytical methods.•Method Development and Validation: Develop and validate analytical methods for small molecule API, oral solid dosage, and biological products. Generate and qualify working standards, validate the methods as per ICH guidelines.•Analytical Investigations and OOS/OOT Handling: Conduct thorough analytical investigations and handle out-of-specification (OOS) and out-of-trend (OOT) results. Identify root causes, propose corrective actions, and implement preventive measures. Maintain detailed documentation of investigations in accordance with regulatory guidelines.•Regulatory Support and Dossier Authoring: Provide regulatory support by contributing to the authoring of dossier sections, including analytical method descriptions, validation reports, stability data, and responses to regulatory inquiries. Ensure compliance with GMP, ICH, and other relevant regulations.•Project Management: Manage analytical projects, ensuring adherence to timelines, resource allocation, and budgetary requirements. Coordinate activities with cross-functional teams, including research scientists, quality control personnel, and regulatory affairs.•Stability Program Management and LIMS: Oversee stability programs, including sample management, storage, testing, and data analysis. Utilize Laboratory Information Management Systems (LIMS) to maintain accurate and traceable data.•Compliance with GMP and GDP: Maintain a comprehensive understanding of regulatory guidelines and actively implement quality systems to meet regulatory expectations.• Data Analysis and Reporting: Analyze experimental data, interpret results, and prepare comprehensive reports. Ensure accuracy, clarity, and adherence to regulatory guidelines. Utilize Microsoft tools, especially Excel, for data analysis and report generation.

  • Group Lead

    • May 2017 - Sep 2020

• 

  Ajanta Pharma Ltd

  • Mumbai Area, India

  • Research associate

    • Nov 2015 - Apr 2017
    • Mumbai Area, India

• 

  Virchow Biotech Pvt Ltd.

  • Hyderabad Area, India

  • Analytical Research Associate

    • May 2013 - May 2015
    • Hyderabad Area, India

• 

  Gunstones Bakery

  • Dronfield, England, United Kingdom

  • Production Executive

    • Dec 2011 - Jan 2013
    • Dronfield, England, United Kingdom

    Prepared ingredients, including dough, batters, fillings, and other components, according to recipes and production schedules.Operated bakery machinery and equipment, ensuring proper settings and adjustments for optimal production.Conducted regular quality control inspections, identifying and removing defective products.Packaged bakery items in appropriate containers or wrapping materials, applying accurate labels and seals.Maintained cleanliness and sanitation in the production area, equipment, and utensils.Assisted with inventory management, monitoring stock levels and reporting any shortages or discrepancies.Complied with food safety regulations and followed safety protocols to prevent accidents and ensure product safety.Communicated effectively with team members and supervisors regarding production issues and concerns.Contributed to process improvements and provided suggestions for increased efficiency.