Officer/ Sr. Officer-ADL (Documentation)

3 - 7 Years of Experience rupess outline icon

Not disclosed time outline icon

Full Time

Stallion Laboratories Pvt Ltd

time outline icon Bavla, Gujarat, India

Posted on 09-10-2024

125 Views

1 Vacancy

Description

Method Development: Develop, validate, and optimize analytical methods for raw materials, intermediates, and finished products to ensure quality and compliance with regulatory requirements.
Instrument Operation and Maintenance: Operate and maintain analytical instruments such as HPLC, GC, UV, and FTIR, ensuring they are calibrated and functioning properly for accurate testing results.
Sample Analysis: Perform analysis of samples (raw materials, in-process, stability, and finished products) using validated methods to assess their quality, purity, and consistency.
Data Documentation: Accurately document all experimental data, analysis results, and observations in lab notebooks or electronic systems, ensuring compliance with Good Laboratory Practices (GLP).
Troubleshooting and Problem Solving: Identify issues in analytical methods or instruments, troubleshooting errors and implementing corrective actions to ensure reliable results.
Regulatory Compliance: Ensure that all analytical procedures adhere to regulatory guidelines (such as ICH, FDA, or EMA) and maintain compliance with Good Manufacturing Practices (GMP) and safety standards.
Collaboration with R&D and QA Teams: Work closely with R&D, quality assurance, and production teams to support product development and ensure the consistency and quality of formulations.
Report Preparation: Prepare detailed reports of analytical findings, method validations, and stability studies, presenting results to management and regulatory authorities as needed.