|
|
| Entreprise: |
Kelly services (Suisse) SA |
|
| Intitulé: |
QA Analyst |
| Secteur Emploi: |
Contrôle Qualité |
| Localisation de l'emploi: |
Suisse |
| Description: |
Responsible for the review of executed batch records and ensures that all changes to the process are captured through proper change control practices.
Responsible for the review of executed validation of drug product / API processes and ensures that all changes are captured through proper change control practices.
Responsible for the review and archiving of the stability and release raw data, analytical documentation and reports for compliance to GMP, as appropriate
Responsible for the review and archiving of the method development and validation raw data, analytical documentation and reports for compliance to GMP as appropriate.
Assist in managing the change control for equipment, methods and specifications.
Writes new and/or revises Standard Operating Procedures.
Circulation (to supervisor) of approval, or rejection of, any necessary or related OOS and deviation reports.
Preparation of the Release dossier.
|
| Capacités Requises: |
Education/experience
BS/BA in Analytical Chemistry, life science or relevant discipline.
1 to 3 years experience in a Quality Control and/or Quality Assurance position in a pharmaceutical company.
Good working knowledge of the cGMP and their practical application in a pharmaceutical company.
Solid understanding of manufacturing process and test method development requirements, both scientific and regulatory.
Excellent investigational skills and QA problem solving skills, has a keen eye to catch the subtle signals and differences between development batches to identify quality, and/or performance differences between trial batches. |
| Langues Requises: |
Anglais-Très BonFrançais-Très Bon |
| Type de Contrat: |
Temps Plein |
| Salaire Annuel: |
Non spécifié |
| Date d'Affichage: |
2009-10-08 |
| Niveau d'Etudes: |
Licence |
| Années d'Expérience: |
1 à 2 Ans |
| Entreprise: |
Kelly services (Suisse) SA |
| Nom: |
Kelly Scientifc Resources |
| Téléphone: |
0041 22 737 12 01 |
| Fax: |
0041 22 737 12 13 |
| Methode de Contact Préférée: |
E-mail |
| Preferred Language of Resume/Application: |
French |
|
|
|
