Sun Pharmaceutical Industries Ltd is a global leader in the pharmaceutical industry, known for its commitment to high-quality, innovative products. With a focus on developing and delivering a wide range of generic and specialty pharmaceuticals, Sun Pharma aims to improve the health and well-being of patients around the world. The company’s extensive R&D efforts are dedicated to developing new formulations, APIs, and advanced drug delivery systems.
Primary Responsibilities
As an Executive in the R&D department at Sun Pharmaceutical Industries, your key responsibilities will include:
- Analytical Method Development: Developing analytical methods for Active Pharmaceutical Ingredients (API) and New Chemical Entities (NCE) samples.
- Sample Analysis: Conducting analyses of raw materials, intermediates, and API/NCE samples using techniques such as gas chromatography (GC), liquid chromatography (LC), and chemical analysis.
- Method Validation: Validating methods to assess the purity and impurity levels of APIs and excipients.
- Troubleshooting: Identifying and resolving various analytical issues related to different products.
- Equipment Maintenance: Performing maintenance, calibration, and troubleshooting of High-Performance Liquid Chromatography (HPLC) and Gas Chromatography (GC) instruments.
- SOP Preparation: Developing standard operating procedures (SOPs) related to instruments and systems used in the analytical process.
- Method Transfer: Facilitating method transfer and conducting method demonstrations at other locations as required.
- Documentation: Preparing essential documentation such as Analytical Test Protocols (ATP), development reports, validation protocols, validation reports, and Standard Test Procedures (STP).
- Compliance: Working in accordance with current Good Manufacturing Practices (cGMP) and OECD Good Laboratory Practices (GLP) to ensure compliance with regulatory standards.
Qualifications and Skills
To be considered for this position, candidates should ideally have:
- A relevant degree in Chemistry, Pharmaceutical Sciences, or a related field.
- Prior experience in analytical method development and validation in a pharmaceutical R&D environment.
- Proficiency in using analytical instrumentation, particularly HPLC and GC.
- Strong troubleshooting skills and the ability to resolve analytical issues effectively.
- Knowledge of cGMP and GLP regulations and practices.
- Excellent documentation and communication skills.
