- Initially Day Work, progressing to 3 cycle, 12 hours Days and Nights
- €35,000 basic plus shift allowance 25%
- Health Insurance, Pension , Great Place to Work
Within this role you are responsible for the coordination, operation and maintenance of the packaging lines in support of manufacturing requirements, and to ensure the process meets cGMP (current Good Manufacturing Practices) and company standards.
- Set up, coordinate, regulate and troubleshoot packaging assembly line equipment in a biologics processing environment for plasma derived pharmaceuticals.
- Perform visual inspection of product vials in accordance with specifications.
- Manually, or with the help of material handling equipment, load, unload, palletize, and distribute materials and products.
- Adhere to procedures and practices and maintain compliance with applicable departmental, corporate, industrial standards and/or applicable health, safety and regulatory requirements of a competent regulatory body.
- Responsible for the accuracy and completeness of batch documentation and material reconciliation.
- Responsible for cleaning facilities and equipment and for ensuring packaging machineries are maintained in proper working order. Perform basic calibration, preventive maintenance and repair work.
- Recommend and implement measures to improve production methods, equipment performance, facility layout, and quality of product.
- Maintain a quality presence to ensure compliance with all regulatory requirements.
- Maintain current knowledge of regulatory and industry standards.
- Generate thorough written reports, when required, that summarize investigations performed for out-of-specification results or out-of-procedure events.
- Participate in regulatory and internal inspections/audits including providing written responses as applicable for area of responsibility.
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