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Chemisch labo PE
The incumbent is responsible for one or more of the following activities: the study, the validation and implementation of chemical test/assay methods, cleaning validation analytical assays and equipment used in the chemical lab. The incumbent is also responsible for the purchase of new lab equipment and improvement of existing analytical methods.
- Must become an expert for the assigned projects in one or more domains of:
- Qualification of laboratory equipment
- Validation of analytical methods
- Cleaning validation analytical methodology
- Test/assay method development
- Problem solving for routine analytical methods and equipment
- Responsible for the validation of one or more of the mentioned activities:
- Preparation of the URS/FS
- Preparation of the validation plan and protocol
- Coordination and follow-up of the practical execution of the validation tests
- Preparation of the final validation report
- The incumbent directs analysts, who are appointed to specific tasks for the assigned projects. He/she is responsible for the reliability of the obtained results and final validation reports.
- The incumbent performs, when needed, analytical testing or equipment validation/installation tests according to cGMP and Pfizer guidelines.
- Proposes a program for qualification or re-qualification of methods and equipment:
- Documented in a rationale
- Writes protocols describing the tests to be done for qualification and re-qualification
- Writes associated SOP’s or Test/Assay procedures
- Assures proper training and development of personnel, concerning the assigned projects.
- He/she assures that test methods used comply with current legal and Pfizer standards.
- Prepares a maintenance/calibration program for concerned equipment according to GMP requirements an Pfizer guidelines.
- Improves productivity and avoids unnecessary costs in relation to the assigned projects and plans for timely implementation.
- The incumbent coordinates chemical lab activities with other Pfizer-Puurs departments such as Engineering, Production, Maintenance, Microbiological Lab, also with other Pfizer plants and Third Party Manufacturers.
- The incumbent proposes for his/her expert domain personnel and equipment budgets and prepares comparative studies on equipment to be purchased.
- He/she is responsible for the safety in his/her expert domain.
- The incumbent will participate in corporate and site teams related to his/her expert domains.
- The incumbent will participate in formal meetings with laboratory management that will be held on a regular basis to discuss progress on projects.
Desired Education level:
This function requires a university degree in the chemical, pharmaceutical and/or biological engineering or scientific field.
2. Formal education
Following, although not limiting, educations are acceptable: Bio Engineer, Pharmacist or Master Chemistry.
3. Experience required
The candidate should have experience in analytical chemistry through work in industry or equivalent research experience.
Knowledge and understanding of cGMP is a must.
Must have good knowledge of analytical chemical techniques and must be familiar with statistical evaluation of results.
4. Specific training and skills
Good analytical and problem solving skills.
Work efficiently with people of different backgrounds.
The candidate must write and speak Dutch and English fluently.
The candidate must have a good understanding of French and German.