Assistant Manager - Packaging & Development

As an Authorization & Review specialist, you will be responsible for reviewing and signing various documents including Exhibit Batch Packing Records, Batch Protocols, Batch Reports, Packaging Trial Batch Protocols, Master Packaging Records, and Bill of Materials. Your attention to detail is crucial in ensuring accuracy and compliance with regulatory standards. Your key responsibilities will include: - Preparing and reviewing Exhibit Batch Batch Production Records (BPRs) - Ensuring strict adherence to cGMP, GDP, regulatory compliance, and Quality Management System (QMS) activities within the PDL department In terms of operational oversight, you will: - Monitor the execution of Scale-up, Feasibility, and Exhibit batches in the packaging area - Prevent mix-ups and cross-contamination - Manage incidents, deviations, and change controls related to packaging - Ensure readiness and execution of Moisture Vapor Transmission Rate (MVTR) studies Your role will also involve cross-functional coordination where you will: - Collaborate with SCM, F&D, and P&D teams for product transfers - Prepare packaging plans for scale-up, exhibit, and validation batches in coordination with relevant departments Additionally, your technical evaluation and execution tasks will include: - Evaluating change parts required for various batches - Conducting machine equivalency comparisons - Executing packaging trials, preparing reports, and maintaining lab notebooks Furthermore, your problem-solving skills and commitment to continuous improvement will be essential as you: - Troubleshoot packaging-related issues - Conduct investigations and root cause analysis - Undertake any other duties assigned by superiors to ensure operational efficiency and compliance within the department.,