Qualification Expert Analytical Instrumentation

Role Overview: You will be responsible for performing qualification assessments on analytical instruments to ensure compliance with regulatory requirements and industry standards. Your role will involve developing and executing qualification protocols, collaborating with cross-functional teams, troubleshooting issues, staying updated with industry trends, and providing technical expertise and support to internal teams. Additionally, you will be expected to continuously improve the qualification processes to enhance efficiency, accuracy, and compliance. Key Responsibilities: - Perform qualification assessments on analytical instruments - Develop and execute qualification protocols (IQ, OQ, PQ) - Collaborate with cross-functional teams to ensure alignment on qualification processes - Ensure proper documentation and maintenance of all qualification activities - Troubleshoot and resolve any issues or discrepancies during qualification - Stay updated with industry trends, regulations, and best practices - Provide technical expertise and support to internal teams - Continuously improve qualification processes Qualification Required: - B.E./B.Tech/bachelor's or master's degree in chemistry, Analytical Chemistry, or a related field - 10+ years of experience in the field - Solid understanding of analytical instrumentation principles and technologies - Proven experience in qualifying and validating analytical instruments - Knowledge of software validation and operation of CDS like Empower, Chromeleon - Familiarity with relevant regulatory requirements and standards (FDA regulations, GMP guidelines) - Strong analytical and problem-solving skills - Excellent documentation and record-keeping abilities - Effective communication and interpersonal skills - Ability to work independently and prioritize tasks in a fast-paced environment Additional Company Details: The company values adherence to appropriate standards as defined in the Quality Manual, SOPs, ethical guidelines, health, safety, environment (HSE), and information security (ISEC) guidelines. Measurable contributions to increasing efficiency and productivity in the work related to assigned projects are encouraged. Feedback from other team members/leaders and annual individual and team objective setting are important aspects of performance evaluation. Note: The skills required for this role include knowledge of laboratory equipment, laboratory equipment qualification GMP, SOP (Standard Operating Procedure), and technical writing.,