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1 - 6 years
2 - 6 Lacs
Hyderabad
Work from Office
JOB DESCRIPTION 1) ARD Scientist (Analytical Research & Development Scientist) Positions Sr Scientist -1 Junior Scientist-2 Job Description: ARD Sr Scientist/Jr Scientist capable in developing and validating analytical methods and Validation including calibration to ensure the quality and stability of pharmaceutical products. Key Responsibilities: Develop and validate analytical methods for drug substances and drug products. Perform analytical testing such as HPLC, GC, and wet analysis. Interpret analytical data to assess product quality, purity, and stability. Implement GLP & GDP practices. Prepare technical reports and documentation for regulatory submissions. Collaborate with the FRD & DQA to support product development. Troubleshoot analytical method issues and recommend improvements. Qualifications: Masters degree or Ph.D. in instrumental analysis, Analytical Chemistry, or related discipline. Expertise in analytical techniques such as HPLC, GC, and spectroscopy. Strong knowledge of regulatory guidelines such as ICH and FDA. Good documentation and report-writing skills. Problem-solving and analytical thinking abilities. Minimum 3(or) More Years for Junior scientist of experience in ARD /Q.C . For Sr Scientist 8 (or) more years of experience is desired 2) FRD Scientist (Formulation Research & Development Scientist) Positions Sr Scientist -1 Junior Scientist-2 Job Description: FRD Sr Scientist/Jr Scientist is responsible for the research and development of pharmaceutical formulations, ensuring the products are safe, stable, and effective for consumption. Key Responsibilities: Design, develop, and optimize formulations for pharmaceutical or nutraceuticals Etc. Implementation of QbD . Conduct experiments to test product stability, and efficacy. Prepare technical documents, including formulation protocols and reports. Collaborate with cross-functional teams such ARD, DQA Etc to ensure compliance. Troubleshoot formulation issues and propose solutions. Qualifications: Masters degree in pharmaceutics or Ph.D. in Pharmaceutics & Equivalence, Minimum 3(or) More Years for Junior scientist of experience in FRD /R&D . For Sr Scientist 8 (or) more years of experience is desired Strong understanding of Good Manufacturing Practices (cGMP). Problem-solving skills and GDP implementation Skills in usage of software for developing of formulation and characterization. Excellent communication skills to present findings and collaborate with teams. Exposure in developing Liquid Orals, Solid Orals, Semi-Solid Orals. Nano formulations will be preferred 3) DQA Team (Development Quality Assurance Sr. Executive) Positions Sr Executive -1 Jr Executive -1 job Description: DQA Sr. Executive should monitor the quality assurance processes during product development, ensuring that all stages comply with quality standards and regulatory requirements and product specification need as per ICH Guidelines. Key Responsibilities: Lead quality assurance activities for product development, including design, testing, and validation stages. Ensure compliance with regulatory guidelines and quality standards (e.g., FDA, EMA, GMP). Develop and implement quality control procedures for new product development. Conduct internal audits and prepare quality assurance reports. Collaborate with R&D, ARD to implement the quality issues. Manage risk assessment processes and ensure continuous improvement in quality systems. Should have knowledge in QbD system for product development. Qualifications: Minimum experience should be 6-8 Years for sr executive and 1 to 3 years for junior executive in DQA (or) Q.A Bachelors or Masters degree in Quality Assurance /Analysis/Pharmaceutics, In-depth knowledge of cGMP, GDP, GLP, ICH and regulatory requirements and implementation. Excellent communication and problem-solving skills.
Posted 2 months ago
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