IVD Manufacturing Executive

As a Manufacturing Executive in Reagent Manufacturing at our client, a leading MedTech company in Bangalore, you will play a crucial role in the production of buffers and solutions for automated medical devices. Your responsibilities will include: - Preparing buffers and solutions following pre-approved SOPs and batch production records. - Measuring and weighing chemicals accurately using calibrated instruments. - Formulating and preparing reagents in line with standardized procedures and specifications. - Performing buffer filtration, monitoring pH levels, and ensuring batch compliance. - Supporting investigations and deviations related to buffer preparation. - Operating in a classified cleanroom using aseptic techniques and proper gowning. - Maintaining workspace cleanliness adhering to GMP, GLP, and ISO standards. - Performing cleanroom operations including machine setup, in-process inspection, filling, and packaging. - Following gowning/de-gowning protocols to prevent contamination. - Handling materials and finished goods within the cleanroom per SOPs. - Conducting in-process quality checks to ensure compliance and product standards. - Identifying and resolving issues during the manufacturing process (e.g., equipment faults, deviations). - Performing routine equipment cleaning and maintenance. - Completing batch records, logs, and inspection reports accurately. - Contributing to process improvement and participating in problem-solving initiatives. - Ensuring compliance with GMP, GDP, and ISO regulatory guidelines. In addition to your key responsibilities, you will need to have the following qualifications: - Bachelor's degree in Biotechnology, Biochemistry, or a related field. - 2-3 years of relevant experience in IVD or related sectors. - Mandatory experience in buffer preparation and cleanroom operations. - Familiarity with automated filling machinery. - Prior experience in the medical device industry is preferred. - Strong understanding of cleanroom protocols and GMP compliance. Your role may also involve physical requirements such as standing for long durations, lifting heavy items, and performing repetitive tasks. Additionally, proficiency in Kannada and English languages is required for effective communication within the team and with stakeholders.,