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Packaging Operations Manager
2 months ago
We are seeking a skilled Packaging Engineer to lead our strategic and operational projects at our site. As a key member of our team, you will be responsible for coordinating and managing technical activities, collaborating with cross-functional teams, and ensuring compliance with current Good Manufacturing Practices (cGMP), Health Safety Environment (HSE), and regulatory requirements.
Key Responsibilities- Lead and coordinate type 1 and type 2 validation projects, including improvement and scale-up initiatives.
- Manage technical activities on site level for assigned projects, including molding, finishing, packaging, metrology, process, technology transfer, analytics, capacity, and resources.
- Collaborate with a cross-functional team to lead projects and provide technical expertise.
- Define and monitor project scope, timing, and progress.
- Initiate change control in systems and ensure approval and closure.
- Coordinate feasibility, regulatory, and validation batches at site.
- Ensure all activities are performed to current standards.
- Lead and investigate nonconformance investigation teams for assigned projects.
- Prepare and deliver validation deliverables within given timelines.
- Close projects and submit original validation documents within stipulated time.
- Complete all assigned trainings before deadlines.
- Adhere to local policies as per associate handbook.
- Support ISRM Sponsor and responsible ISRM Manager/Lead Coordinator in implementing, maintaining, and improving business information management within areas of accountability.