GMP Qualification and Validation Services - Normal

Beschreibung

Main purpose: Execution of the practical project work in a development and or cGMP enviroment, interpretation of the results and reporting. Ability to make scientifically and technically sound conclusions contributing to the improvements of processes and procedures from a technological perspective. Writing of studyplans in consultation with the senior position. Key responsibilities: 1. Practical realization of the project work in line with established procedures (MBRs,SOPs) and regulations (cGMP) 2. Documentation of experiments and / or GMP CTM productions and results according to procedures 3. Evaluation of results together with the senior position 4. Responsible for writing validation plans, validation reports, SOP's 5. Implementation of new techniques and technologies 6. Internal organization of the lab or cleanroom, including GXP and HSE aspects 7. Stay up to date on novel technologies related to the work area 8. Communication with external parties for purchasing and commissioning of new equipment 9. Trouble shooting / solving 10. Actively participate in the integration of cGMP compliance, process excellence and process development aspects of CTM. Specific process-related responsibilities / accountabilities (PDVS): Execute experiments or productions according to predefined Study Plans or batch records ? Development / qualification / validation ? USP / DSP/Formulation processes 6. Internal organization of the lab or cleanroom, including GXP and HSE aspects 7. Stay up to date on novel technologies related to the work area 8. Communication with external parties for purchasing and commissioning of new equipment 9. Trouble shooting / solving 10. Actively participate in the integration of cGMP compliance, process excellence and process development aspects of CTM. Specific process-related responsibilities / accountabilities (PDVS): Execute experiments or productions according to predefined Study Plans or batch records ? Development / qualification / validation ? USP / DSP/Formulation processes ? Stability / Comparability studies ? Characterization /(Pre) Process Robustness/Fill & Finish Performance Indicators: ? Accomplishment of targets & objectives / progress of projects ? Quality, efficiency, accuracy and reliability of work ? Planning, adherence to timelines ? Effective and efficient use of equipment ? Operational troubleshooting capabilities ? Innovating capabilities ? Communication capabilities ? Quality of SOP's and other cGMP relevant documentation ? Personal targets Specific professional/technical requirements: Education: MSc/BSc level or equivalent in Bio-Process Engineering
Languages: English, preferably language of local organisation Specific Knowledge: Applicable scientific/technical background in medical device and clean room processing for the areas of expertise Experience: Several years of relevant experience as technician or equivalent in a cGMP environment Other: Communication skills and basic proj mngt skills Leadership and Functional Competencies Precision Independency Adaptability Organisational Commitment Analysis Planning & Organising Self-awareness Result-orientation Coaching High-impact delivery