30 jul
|
PCI Pharma Services
|
España
30 jul
PCI Pharma Services
España
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our integral network to pioneer and shape the future of PCI.
The Level VI Production Operator (Technician IV) executes, runs autonomously, advises and leads complex activities of aseptic manufacturing of batches, billable activities, or continuous improvement activities required in the production department, following instructions and standard operating procedures in accordance with the AEMPS, FDA, and other regulatory agencies under supervision. In addition, they must ensure the execution of production plans, following all company safety guidelines. A high level of detail is required due to the complexity of the activities to be performed. The minimum training time for this is normally 5 years.
- Comply with manufacturing area safety regulations and work practices in accordance with all company health, safety and environmental programs.
- Work as a team, being approachable, practical, motivating, able to support and inspire your co-workers.
- Comply with the schedule by following the prioritization instructions of their senior managers to ensure compliance with the schedules together with the department head.
- Collaborate in the identification of opportunities for continuous improvement to improve processes and practices.
- Comply with the requirements of cGMP, AEMPS, FDA and other regulatory agencies that have been implemented in the plant, as well as with the department’s objectives and corporate quality standards.
- Collaborate and participate in preparing for inspections by regulatory agencies or clients.
- Participate in the control of the stock of plant consumables, to guarantee their availability.
- Collaborate in the investigations of the different quality events (deviations, capas, change controls).
- Inform t
📌 Manufacturing Technician I (España)
🏢 PCI Pharma Services
📍 España