Job Responsibilities: 1. Document analysis procedures and the test results mainly bioburden testing, spectrophotometric testing and mechanical studies using UTM machines 2. Document product stability studies are completed satisfactorily and supported by correct product sample analysis 3. Establish a tracking mechanism for customer & field complaints and suggest corrective actions Profile: 1. You have experience of around 3 or more years in pharmaceutical industry 2. Educational Qualification - M.Sc./M.Pharm degree with strong interest in quality control documentation 3. You work accurately, technically minded and able to work independently after training in the matter entrusted to you. Experience in a formulations/ API industry is an asset

1. Maintain the QMS documents on the lines of ISO 13485 and GMP 2. Responsible for control of all levels of documents & their history in accordance with EU MDR 3. Coach and Guide the team to support company goals by : Identifying factors that are critical to prospective and retrospective stability studies Participate in the new product registration/ life-cycle management discussions to provide inputs on the procedure for analysis, mainly validations

Background Industry: Pharmaceutical Formulations (Injectables) or Medical Devices (EU Class 2b or higher) manufacturing company with turnover higher than 300 Cr Required Skills: Experience in QA management across multiple projects involving the implementation of the Company's QA processes and strategies. The projects include IPQA, QMS, cGMP, validation and Compliance related assignments Ensure that the norms and laws, set by regulatory authorities, are met. Preferentially an audit experience for FDA, EU MDR, PMDA, SFDA, TGA and KFDA requirements Excellent knowledge of QA processes including of risk management, clinical data management and electronic data management systems. Ability to handle adverse events and rectify non conformities reported in inspections