Operations Investigator - DPI

The Operations Investigator - DPI is responsible for investigating manufacturing and packaging deviations, non-conformances, and quality events within a pharmaceutical manufacturing environment. This role leads root cause investigations and drives the development and implementation of effective Corrective and Preventive Actions (CAPAs) to ensure product quality, regulatory compliance, and continuous improvement. Key ResponsibilitiesDeviation & Investigation Management Investigate manufacturing and packaging deviations and non-conformances Perform root cause analysis and develop corrective and preventive actions (CAPAs) to prevent recurrence Conduct in-depth interviews and gather data to support root cause conclusions, product impact assessments, and CAPA initiation Prepare detailed investigation reports for medium- and high-severity events, including conclusions and recommendations Present investigation findings and recommendations in cross-functional meetings Documentation & Data Review Review completed Batch Manufacturing Records (BMRs) and logbooks in compliance with cGMP requirements Review, edit, and revise controlled documents (batch records, SOPs, logbooks) to ensure procedural compliance Monitor production processes to collect investigation-relevant data and assess effectiveness of implemented changes Gather, trend, and analyze process data to improve consistency, timeliness, and compliance Cross-Functional Collaboration Lead or participate in cross-functional investigations involving Manufacturing, Packaging, Quality, Engineering, and other departments Coordinate and facilitate investigation meetings across multiple functional teams Train new employees on investigation processes, tools, and documentation standards Quality & Risk Management Prepare product complaint investigations and support investigations related to quality events, OOS, and OOT results Support equipment qualification activities, including IQ, OQ, and PQ, and prepare related documentation Perform risk assessments and mitigation activities using tools such as FMECA (Failure Modes, Effects, and Criticality Analysis) Education & Experience Education: Bachelor's degree (or higher) in Pharmaceutical Sciences, Chemistry, or a related scientific field Experience: Minimum of 2-5+ years of experience in pharmaceutical manufacturing, quality investigations, or related functions Skills & Competencies Strong working knowledge of current Good Manufacturing Practices (cGMP) Proficiency with Microsoft Office and quality systems such as SAP and TrackWise Strong analytical, organizational, and problem-solving skills Excellent written and verbal communication skills in English Ability to multitask and work effectively in a fast-paced environment with tight deadlines Strong attention to detail and documentation accuracy Ability to collaborate effectively across cross-functional teams Experience interacting with regulatory authorities preferred Knowledge of global regulatory requirements and quality standards Ability to follow gowning procedures and work in a production environment

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