Investigations Specialist

Job description:Responsible for leading investigations into product deviations, ensuring that the root causes are identified, and appropriate corrective and preventive actions are taken. The role requires a deep understanding of regulatory requirements, quality systems, and root cause analysis techniques.The manager ensures that deviations are thoroughly documented, aligned with industry regulations, and resolved in a manner that minimizes risk to product quality and customer safety. Additionally, the role involves training staff, improving processes, and collaborating with multi-functional teams to develop a culture of continuous improvement in product quality management.KEY RESPONSIBILITIES:Manage the deviation process from initiation to closure. Ensure that all deviations (i.e., discrepancies from standard operating procedures, specifications, or regulations) are gathered, investigated, and properly documented.Coordinate and lead thorough investigations of product deviations, identifying root causes, and evaluating the impact of the deviations on product quality, safety, and regulatory compliance.Work with teams across departments (e.g., Quality Assurance, Manufacturing, R&D, Regulatory Affairs) to gather data, perform investigations, and identify potential process improvements.Lead and guide the investigation team in conducting detailed root cause analysis to resolve underlying causes of product deviations.Analyze the potential impact of deviations on product quality, customer safety, regulatory compliance, and business operations. This includes resolving if the deviation is isolated or if it affects multiple batches or products.Based on investigation findings, be responsible for the development and implementation of corrective and preventive actions (CAPA) to address the root cause of the deviation and prevent recurrence.Ensure that CAPA plans are appropriately designed, implemented, and evaluated for effectiveness. Verify that actions taken resolve the issue and lead to sustained improvements.For critical deviations, ensure proper and timely reporting to regulatory bodies, following industry-specific regulations on how to handle quality deviations, adverse events, or product recalls.Ensure all product deviations are thoroughly documented, including investigation findings, root cause analysis, corrective actions taken, and any follow-up activities. These records must be stored in accordance with regulatory and company policies!Prepare detailed deviation investigation reports, summarizing the issue, investigation findings, corrective actions, and any preventive measures put in place.Track deviation metrics, generate regular reports, and analyze trends to identify recurring issues or areas of risk that require attention!If a deviation is related to raw materials or external suppliers, work closely with the supplier management team to address the issue and prevent future occurrences. Required Skills:We are looking for a bachelor's degree in engineering (e.g., Mechanical, Chemical, Industrial), Manufacturing, Life Sciences, or a related field.Direct experience managing deviations and investigations in a manufacturing or production environment is highly valued.Expertise in root cause analysis methodologies, including tools such as the 5 Whys, Fishbone diagrams, FMEA, and other quality improvement techniques.Knowledge of Good Manufacturing Practices (GMP), ISO standards, and relevant regulatory requirements (e.g., FDA 21 CFR Part 820 for medical devices)We are looking 5-10 years of Quality / relevant process experience in regulatory environmentExcellent communication skills to convey complex investigation results, corrective actions, and technical details to various collaborators, including management, regulatory bodies, and external auditorsWe are looking 3-8 years of people leadershipAbility to lead and handle an onshore and offshore teamEnd to end process understanding.

Created: 2025-02-19