<p>Essential Duties and Responsibilities</p> <ul> <li>Support packaging operations through execution of projects related to process optimization, validation, and equipment qualification. </li><li>Prepare, review, and maintain GMP documents, including SOPs, batch records, protocols, and reports, ensuring accuracy and compliance with regulatory and site standards. </li><li>Assist in the management, investigation, and documentation of customer complaints, deviations, and CAPAs to ensure timely closure and preventive action implementation. </li><li>Participate in root cause analyses, risk assessments, and continuous improvement initiatives (e.g., Kaizen, Lean, Six Sigma projects) to enhance process performance and product quality. </li><li>Support packaging validation and qualification activities, including documentation and data collection. </li><li>Monitor compliance within the packaging area to ensure readiness for regulatory inspections and internal audits at all times. </li><li>Assist in maintaining oversight of change controls, ensuring proper documentation and impact assessment for packaging processes. </li><li>Support the implementation of process improvements to enhance Packaging OEE (Overall Equipment Effectiveness) and reduce waste. </li><li>Collaborate with cross-functional teams to troubleshoot packaging issues and implement sustainable solutions. </li><li>Provide regular project updates, including progress tracking, risks, and mitigation strategies, to management and stakeholders. </li><li>Ensure proper control, storage, and archival of packaging-related documentation per data integrity and document retention policies. </li><li>Support internal and external audit activities through document preparation, participation, and follow-up actions. </li><li>Promote a culture of quality, safety, and continuous improvement within the packaging operations. </li></ul> <p>Key Competencies (knowledge, skills and abilities every person must possess to be successful)</p> <ul> <li>Strong understanding of cGMP, GDP, and pharmaceutical quality system requirements. </li><li>Excellent analytical and problem-solving skills with the ability to interpret data and identify improvement opportunities. </li><li>Knowledge of Lean, Six Sigma, and continuous improvement methodologies (Green Belt certification preferred). </li><li>Detail-oriented with excellent organizational and documentation management skills. </li><li>Strong communication and interpersonal skills; able to interact effectively with cross-functional teams and external stakeholders. </li><li>Proactive, adaptable, and able to manage multiple priorities in a fast-paced, regulated environment. </li><li>Professional demeanor with a commitment to maintaining confidentiality and ethical standards. </li><li>Skilled in critical thinking, with the ability to evaluate alternative solutions and propose effective corrective actions. </li></ul>