3 Analytical Validation Jobs

We are seeking an experienced Lead in analytical development who can plan analytical projects based on priorities and established timelines, provide timely analytical delivery for stability testing, test method development/validation, method transfers and other related requests from Research & Development (R&D) or formulation development. Roles & Responsibilities You will have to prepare and review of technical documents e.g. stability reports, method transfer and method validation protocol and reports, etc. You need to manage communication with stakeholders such as project leaders, product development, analytical teams and other business partners You need to facilitate productivity improvement through proper planning of analytical activities and resource optimization You need to co-ordinate and follow up with external labs including training of their staff. You will need to review of analytical data for accuracy, compliance to quality requirements and completeness e.g. lab notebooks, raw data, system entries, etc. You will have to review of technical documents such as analytical reports, method transfer /method validation protocols, reports, etc. You will have to participate in handling and resolution of laboratory non-conformances with related documentation You will be responsible for analytical methods and process compliance as per quality assurance requirement. Qualifications Education Qualification - MSc Chemistry, MSc Food Science, B.Tech/M. Tech in Dairy Technology Minimum experience required -6 to 10 years of experience in analytical development department and must have worked on nutritional product portfolio. Skill Attributes Technical Skills Technical expertise related to chemistry, analytical techniques, stability study assessment and advanced research technologies Efficient in MS Office, Word/Excel/PowerPoint functionalities Ability to interact with external labs and 3rd party manufacturing site labs to support product development team. Ability to understand analytical methods defined by global and local bodies Ability to resolve analytical issue associated with different product matrix. Should be familiar with analytical methods defined by national and international bodies like Association of Official Agricultural Chemists (AOAC), Bureau of Indian Standards (BIS) etc. Excellent knowledge of Good Laboratory Practices (GLP), Quality systems, Standard Operating Procedures, latest regulatory trends, and Global regulations as appropriate Data review, interpretation of analytical data and accurate documentation of laboratory investigations. Behavioural Skills Systematic approach and strategic thinking Possess excellent interpersonal skills, communication, coordination, and time-management skills Ability to independently handle teams Excellent oral/written communication and articulation skills Passion for people development Ability to prioritize work and change focus quickly Ability to delegate effectively

We are seeking a highly skilled Analytical Scientist to join our Research and Development team. The successful candidate will be responsible for developing, validating, and implementing analytical methods for the quantification and identification of genotoxic impurities in pharmaceutical products. This role will involve extensive use of chromatography techniques and adherence to regulatory standards. The ideal candidate should have a strong background in analytical chemistry, method development, and data analysis, with a keen eye for detail and a commitment to ensuring the highest quality standards. Roles & Responsibilities You will be responsible to review relevant Literature and stay updated with the latest research and scientific literature relevant to the field of genotoxic impurities and chromatography methods. You will be responsible to develop and optimize chromatography-based methods for accurately quantifying genotoxic impurities in various samples. You will be responsible to address regulatory deficiency queries concerning the analytical methods and data related to genotoxic impurities. You will be responsible to ensure the quality and accuracy of reference standards and working standards used in analytical testing and method development. You will be responsible to develop analytical methods, conduct validation studies to ensure the accuracy and reliability of the methods, and transfer validated methods to the Quality Control (QC) department. You will be responsible to prepare comprehensive reports documenting method development, validation results, and any forced degradation studies performed. You will be responsible to conduct forced degradation studies to identify potential impurities and establish their chemical nature and behaviour. You will be responsible to perform real-time analysis of samples during product development stages to ensure product quality and consistency. You will be responsible for compilation of Stability Data to assess the stability profile of the products under various conditions. You will be responsible to evaluate the effectiveness of the product development strategy and identify any cross-functional issues affecting the process. You will be responsible to identify and plan for the developmental needs of the product, considering factors such as scale-up and potential process improvements. You will be responsible to source and manage the procurement of necessary chemicals, solvents, columns, and other laboratory equipment. You will be responsible to ensure proper maintenance of laboratory equipment as per Good Laboratory Practices (GLP) standards to guarantee accurate and reliable results. You will be responsible to calibrate instruments as per the calibration schedule and strictly follow Standard Operating Procedures (SOPs) to maintain consistency and accuracy. You will be responsible to maintain a clean and organized work area, and ensure that the laboratory environment is controlled at the required temperature for optimal analytical conditions. You will be responsible to keep all relevant documents well-maintained and organized for easy access and compliance with internal and external auditing requirements. Qualifications Educational qualification: Masters in Science/ Organic chemistry Minimum work experience: 4 years of experience in analytical method development Skills & attributes: Technical Skills Have work experience on Process scale up of Active Pharmaceutical Ingredients. Experience in Process Optimization (Manufacturing) Experience in the development and regular analysis in Wet analysis-IR, Ultra Violet, Moisture analysis, Chromatographic techniques Strong understanding of regulatory guidelines and industry standards related to pharmaceutical product development and analysis. Proven experience in method validation and documentation in compliance with regulatory requirements. BehavioralSkills Excellent communication and interpersonal skills. Strong analytical and problem-solving abilities. Ability to work collaboratively with own team and cross-functional teams.

Developing and validating analytical methods for the development of new and existing products Preparation and execution of method validation protocol and report. Designing and executing experiments to develop and validate analytical methods. Documenting and interpreting the analytical data in a timely manner as per GLP / GMP requirements to maintain records and compliance of regulatory norms Perform maintenance and calibration of lab instruments / equipment to get accurate and reproducible analytical result for proper interpretation Ensuring compliance with safety regulations.