Reporting to the Team Leader, the role of the Process Technician (Aseptic Filling) is to provide the necessary production skills to complete sterile filling operations, ensuring safety, cGMP compliance, and cost-effectiveness in meeting production schedules.
Responsibilities
* Perform sterile filling operations in accordance with cGMP, Batch records, SOPs, and local SOPs, ensuring compliance with HSE risk management procedures to meet production targets.
* Transport materials such as pallet trucks, tanks, and rigs using cGMP and BR systems, adhering to SOPs and safety procedures to fulfill production requirements.
* Maintain environmental standards through basic area cleaning, supporting Environmental Monitoring, GMP, and Health & Safety standards.
* Conduct in-process control checks and environmental monitoring to ensure process stability and product quality.
* Accurately complete documentation, including work orders and HSE incident reports, and provide first response to PCS, GLIMS, SAP issues and exceptions.
Experience Requirements
* Experience in sterile product filling, aseptic techniques, and use of isolator technology, with high compliance standards.
* Knowledge of cGMP and proficiency with computer systems such as PCS, GLIMS, SAP.
* Strong documentation skills, literacy, numeracy, and ability to operate material handling equipment like pallet trucks.
* Experience in cGMP sterile production within the biotech or pharma industry.
Education Requirements
* Degree qualification preferred or relevant pharmaceutical experience.
Note: Qualifications and responsibilities may vary based on local legal and educational requirements. Please refer to local job documentation.
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