Our goal is to find a skilled Packaging Operations Manager who can lead and coordinate our daily packaging operations. The selected candidate will be responsible for ensuring production targets are met while maintaining high standards of quality, safety, and regulatory compliance.
Main Responsibilities:
1. Coordinate and oversee daily packaging operations to meet production targets in accordance with GMP, safety, and quality standards.
2. Supervise the day-to-day running of assigned packaging lines by leading and coordinating all line activities, including staffing, scheduling, and equipment setup.
3. Maintain strict compliance with cGMP and SOPs by monitoring all processes and documentation to uphold regulatory standards and site procedures at every step.
4. Collaborate with planning and quality teams to schedule and execute packaging batches, partnering with PPIC and QA to align production plans, secure materials, and manage batch timelines.
5. Verify accuracy and completeness of all production records, including batch records and logbooks, to facilitate batch release and audit readiness.
6. Evaluate and escalate quality or equipment issues to relevant departments in a timely manner, identifying deviations or malfunctions on the line and engaging QA or Engineering for resolution.
7. Direct and mentor line personnel, assigning duties and ensuring proper training is in place, with on-the-job coaching and refresher training as needed.
8. Ensure completion of visual inspection activities and requalification where applicable, coordinating inspector schedules and confirming adherence to AQL standards.
9. Enforce EH&S policies and promote a clean and safe working environment, addressing hazards immediately and conducting regular housekeeping inspections.
10. Support deviation investigations, incident reporting, and CAPA implementation, gathering facts and documenting findings to assist QA in root-cause analysis and corrective actions.
11. Contribute to process improvements and lean initiatives by identifying opportunities to reduce waste, improve yield, or optimize workflow, driving small-scale Kaizen events.
Qualifications:
* Bachelor's degree in Science, Engineering, or a related field.
* 5+ years' experience in a GMP environment.
* Demonstrated experience managing audits, compliance, and continuous improvement projects.
* Green Belt (or higher) in Lean Six Sigma preferred.
* In-depth understanding of packaging processes and equipment.
* Strong leadership, communication, and team development capabilities.
* Analytical thinking, decision-making, and root cause analysis.
* Excellent organizational and multitasking abilities.
* Proficiency in MS Office, MES, ERP (SAP), and Trackwise or similar systems.