WA
Job Description
- Role Purpose: Supports the production process by operating equipment and performing assign tasks in line with quality and GMP requirements Areas of Impact: Production/packaging process Performs operations related to the production of single and multi-component preparations, in compliance with the prescribed procedures with the principles of GMP. Advanced operation, assembly and adjustment of simpler and more complex production equipment, device parameters setting.
- Job Aspect:
- Performs the full range of established procedures such as operating machines and manipulation with material, producing necessary documentation in line with data integrity and GMP, monitoring processes in scope .
- Monitors processes parameters to ensure compliance and eliminate deviations
- Resolves routine issues - trouble shooting
- Has developed proficiency through job related training and considerable on-the-job experience
- Completes work with a limited degree of supervision
- Performs IPC controls within batch production
- Likely to act as an informal resource for colleagues with less experience Responsibility for checking the documentation of the product series in terms of completeness of entries, confirming the compliance of the production process with the requirements of Polish law, EU law, GMP, HACCP requirements and the applicable internal documentation of the Company ;
- Proper operation and taking care of the technical condition, immediate reporting of defects
- Ongoing informing the supervisor about the progress of tasks and possible difficulties in their performance. Immediate notification of any irregularities and abuse to the detriment of the Company and events that may affect the quality of the product Competencies: - Ability to follow process and procedures in line with GMP, EHS, SOP standards - Attention to detail - Learning Agility - May act as mentor for new hires - Digital awareness in frame of related systems - Machine and equipment operation on relevant work place - developed knowledge and experience excellennce in action, adaptation to change, good organization of own work, ability to work under time pressure Capabilities .
- Technical Skills: As per skills matrix per site process Areas of focus: assembly, washing processes, documentation, work with control systems (MES etc.), IPC controls ,manipulation with material, stock adherence, OEE principles, GMP/EHS/FP/SOPs alignment, clean work place Qualifications / Trainings: - GMP certification - Quality / work procedures trainings - EHS qualifications - IT systems qualifications upon required level