Our organization is seeking an experienced leader to oversee daily packaging operations. This Packaging Operations Manager will be responsible for ensuring that production targets are met in accordance with GMP, safety, and quality standards.
Key Responsibilities:
1. To coordinate and supervise daily packaging activities, guaranteeing seamless execution of production plans.
2. Supervise the day-to-day running of assigned packaging lines by leading and coordinating all line activities—including staffing, scheduling, and equipment setup—to ensure smooth and uninterrupted production.
3. Ensure packaging is performed in strict compliance with cGMP and SOPs by monitoring all processes and documentation to uphold regulatory standards and site procedures at every step.
4. Support scheduling and execution of packaging batches in collaboration with planning and quality teams by partnering with PPIC and QA to align production plans, secure materials, and manage batch timelines.
5. Complete and review line documentation (batch records, logbooks) by verifying accuracy and completeness of all production records to facilitate batch release and audit readiness.
6. Escalate quality or equipment issues to relevant departments in a timely manner by identifying deviations or malfunctions on the line and promptly engaging QA or Engineering for resolution.
7. Oversee line personnel, assign duties, and ensure proper training is in place by directing and mentoring operators and line leads with on-the-job coaching and refresher training as needed.
8. Ensure completion of visual inspection activities and requalification where applicable by coordinating inspector schedules, confirming adherence to AQL standards, and tracking periodic requalification.
9. Maintain adherence to EH&S policies and promote a clean and safe working environment by enforcing safety protocols, conducting regular housekeeping inspections, and addressing hazards immediately.
10. Support deviation investigations, incident reporting, and CAPA implementation by gathering facts, documenting findings, and assisting 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, and driving small-scale Kaizen events.
12. Communicate effectively with peers, QA, engineering, and support functions by facilitating clear, timely information flow across teams to resolve issues and align on production goals.
Requirements:
13. Bachelor's degree in Science, Engineering, or a related field.
14. 5+ years' experience in a GMP environment.
15. Demonstrated experience managing audits, compliance, and continuous improvement projects.
16. Green Belt (or higher) in Lean Six Sigma preferred.
17. In-depth understanding of packaging processes and equipment.
18. Strong leadership, communication, and team development capabilities.
19. Analytical thinking, decision-making, and root cause analysis.
20. Excellent organizational and multitasking abilities.
21. Proficiency in MS Office, MES, ERP (SAP), and Trackwise or similar systems.