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Validation of Analytical Methods Specialist
Eingestellt von Harvey Nash IT Recruitment Belgium
Gesuchte Skills: Support
Projektbeschreibung
One of our clients, an international company in the pharmaceutical industry currently requires a Specialist in Validation of Analytical Methods
Start: 15/7/13
Length: min 6 months with a possible extension
Location: South of Brussels
Job Description:
Operational
1. Develop and validate analytical methods to support projects in development in different phases of product development.
2. Perform analyses of raw materials, intermediate products, in bulk or pakaged finished products in
accordance with work instructions and established procedures (stabilities, in-process control, clinical
release, investigation, ...).
3. Ensure stability analyses and clinical release for clinical phases I and II, as well as any analyses in
support to process understanding (IPC test, forced degradation study, multimedia dissolution, ...)
4. Analyze results with readiness to criticize and ensures the consistency of these results with earlier data if relevant.
5. Participate to analytical exercise transfer to QC and subcontractors.
6. Monitor the documentation associated with the analytical laboratory activities by mastering the computer softwares in use at the laboratory (eg Mikado, GLIMS, e-noval, TrackWise, ...).
7. Read and Write in English
Quality:
1. Make sure to have received and understood all the information and instructions required for the tasks
before starting work.
2. Respects the procedures and reports any discrepancies to the responsible
3. Use authorized and validated methods prior to testing, if applicable.
4. Respect and properly maintain the analytical equipment and facilities at disposal.
5. Performs double check the team
The contractor will develop and validate analytical methods for quality control of medication. He
will also participate in the release and stability analyses of raw materials, intermediates, drug substances or drug products. Needs to be able to work in team, under the supervision of a scientist. The number of team members will depend on the project. The contractor will also need to collaborate with Chemical Process Developments or Chemical Pharma Development groups in the Pharmaceutical Sciences Department.
Skills:
- autonomous
- pro-active
- creative, when his/her activities lead him/her to create and develop new analyses method.
Technical expertise and key skills:
- Master/Bachelor/graduate A1: analytical chemistry
- Min 2 years'experience
- International experience a plus
Mandatory skills:
- team player
- exp. in a similar position/environment
- compliant/rigorous
Language skills:
- English: able to read/write scientific documents
- French: mandatory/fluent
Tags: Validation, Analytical Methods, Raw Materials, GMP, Chemistry
Start: 15/7/13
Length: min 6 months with a possible extension
Location: South of Brussels
Job Description:
Operational
1. Develop and validate analytical methods to support projects in development in different phases of product development.
2. Perform analyses of raw materials, intermediate products, in bulk or pakaged finished products in
accordance with work instructions and established procedures (stabilities, in-process control, clinical
release, investigation, ...).
3. Ensure stability analyses and clinical release for clinical phases I and II, as well as any analyses in
support to process understanding (IPC test, forced degradation study, multimedia dissolution, ...)
4. Analyze results with readiness to criticize and ensures the consistency of these results with earlier data if relevant.
5. Participate to analytical exercise transfer to QC and subcontractors.
6. Monitor the documentation associated with the analytical laboratory activities by mastering the computer softwares in use at the laboratory (eg Mikado, GLIMS, e-noval, TrackWise, ...).
7. Read and Write in English
Quality:
1. Make sure to have received and understood all the information and instructions required for the tasks
before starting work.
2. Respects the procedures and reports any discrepancies to the responsible
3. Use authorized and validated methods prior to testing, if applicable.
4. Respect and properly maintain the analytical equipment and facilities at disposal.
5. Performs double check the team
The contractor will develop and validate analytical methods for quality control of medication. He
will also participate in the release and stability analyses of raw materials, intermediates, drug substances or drug products. Needs to be able to work in team, under the supervision of a scientist. The number of team members will depend on the project. The contractor will also need to collaborate with Chemical Process Developments or Chemical Pharma Development groups in the Pharmaceutical Sciences Department.
Skills:
- autonomous
- pro-active
- creative, when his/her activities lead him/her to create and develop new analyses method.
Technical expertise and key skills:
- Master/Bachelor/graduate A1: analytical chemistry
- Min 2 years'experience
- International experience a plus
Mandatory skills:
- team player
- exp. in a similar position/environment
- compliant/rigorous
Language skills:
- English: able to read/write scientific documents
- French: mandatory/fluent
Tags: Validation, Analytical Methods, Raw Materials, GMP, Chemistry
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Sonstiges