QA Investigation

Role Overview: As a member of the ANKLESHWAR QA department, your primary responsibility will involve handling various aspects of quality assurance and investigations related to deviations, out-of-specifications (OOS), out-of-trend (OOT), market complaints, lab incidents, and corrective and preventive actions (CAPA). You will also be actively involved in audits, compliance activities, and leading investigations by forming cross-functional teams (CFTs) to identify root causes and ensure timely completion of investigations. Key Responsibilities: - Handle deviations, OOS, OOT, market complaints, lab incidents, and CAPA effectively. - Conduct audits and ensure compliance with quality standards. - Investigate shop floor incidents to identify root causes. - Form CFTs for investigations and lead the investigative process. - Review investigation plans and provide necessary information and data. - Ensure investigations are completed within the specified timeline. - Prepare, review, and approve investigation reports with clear findings and probable causes of failures. - Participate in Quality Review Meetings to discuss findings and suggest improvement areas based on trend analysis. - Identify improvement opportunities based on trend analysis reports and provide feedback to the site management. - Propose investigation plans and evaluate the impact of failures on distributed batches, manufacturing batches, or process areas. - Conduct root cause analysis and risk assessments to address potential issues. - Collaborate with other functional heads to carry out necessary investigations. Qualification Required: - M.Sc. in Organic Chemistry or PhD with a specialization in organic chemistry. - 3-5 years of experience in Product Development (PD) Lab, Research & Development (R&D), or Quality Assurance (QA) roles. (Note: Additional details about the company were not provided in the job description.),