Role & responsibilities Prepare standard solutions as per requirement.Conduct experiments taking into account the volume and structure of ingredients.Customize formulas and use different reagents to perform the chemical reactions.Ensure compliance with laboratory safety, health and environment.Write technical reports of the test procedure results.Maintain lab equipment and troubleshoot or report on malfunctions.Establish chemical products to improve their quality.Ensure proper usage of equipment and store materials in secure places.Aware of process development and process safety Preferred candidate profile Bachelors/Masters Degree in Science or related field (industrial experience preferred)2-7years of relevant experienceStrong skills to evaluate alternative reaction to meet target.Ability to learn and implement new techniques in laboratory.Aware of Process Development and Process Safety Proficient with computer and information technologyExperience working with chem-draw and Automation.Knowledge of reagents handling mustGood knowledge of Laboratory Safety standards and safe handling of reagentsWell aware of MSDS check and proper care while handling chemistries.Excellent understanding of Chemistry and Research SkillsPerform chemical reaction with minimum supervision.Well aware of Safety, Health and Environment conditions.

Role & responsibilities Prepare and Review SOPs and Guideline for DQA.Formulate Documentation Process for the Key divisions of SRD and ARD.Review documents with respect to drug substance such as protocols, SOPs, test methods, data COAs and report through collaborate with CRD, ARD, and QC scientists.Successfully manage and complete all Audits that come up from time to time and conduct periodic internal audits and ensure compliance as per regulatory requirementsReview process development documents including KSM/KRM identification, specification proposal, analytical method development and validation reports, stability protocols& reports and safety studies.Handle Vendor Qualifications for KSM/KRM, Solvents etc.Ensure Regulatory compliance as per USFDA and other such regulatory bodies.Support and handle all aspects pertaining to new product development patent filing, license approvals etcImpart training to all employees on SOPs/Safety. Support on Onboarding on new employees joining the organizationResponsible for assessing the impact, review and closure of change control requests and deviations.Responsible for CAPA implementations, verifications of and effectiveness.Preferred candidate profile Bachelors or Masters degree in Pharmaceutical Sciences, Chemistry, or related field.Minimum 5-8 years of experience in Quality Assurance, with at least 2 years in a supervisory role in the pharmaceutical industry, specifically with API products.In-depth knowledge of GMP, ICH guidelines, FDA, EMA regulations, and quality systems.Proven experience in conducting internal and external audits, and leading regulatory inspections.Strong understanding of the API development and manufacturing process.Ability to manage cross-functional teams and interact with senior management

Role & responsibilities Maintain laboratory equipment and ensure it is calibrated and functioning properly.Manage inventory of chemicals, reagents, and consumables used in the analytical laboratory.Perform routine and non-routine analysis of raw materials, in-process samples, finished products, and stability samples using various analytical techniques (e.g., HPLC, GC, UV-Vis, MS).Conduct quality control tests to ensure that pharmaceutical products meet specified standards.Collaborate with R&D teams to support drug development projects.Prepare and review quality control documentation such as certificates of analysis (CoAs), standard operating procedures (SOPs), and test reports.Participate in the design and execution of experimental studies to support product development and innovationResponsible to Develop and optimize analytical methods for the identification, quantification, and characterization of pharmaceutical compounds.Validate analytical methods according to regulatory guidelines to ensure accuracy, precision, specificity, sensitivity, reproducibility, and robustness.Analyse data and document results in compliance with standard operating procedures (SOPs) and regulatory requirements.Implement quality assurance protocols to maintain the integrity and reliability of analytical results.maintain accurate and detailed records of all testing procedures, results, and deviations.Preferred candidate profile Bachelors/Masters Degree in Science or related field (industrial experience preferred).Experience of 3-5 years as an Analyst.Proficient with computer and information technology.Knowledge of reagents handling must.Good knowledge of Laboratory Safety standards and safe handling of reagents.Well aware of Safety, Health and Environment conditions.Attention to detail