Stability Officer (BBBH303421) Nyon, Suisse
For our client, GSK, localized in Nyon in Switzerland, we are looking for a 9-month mission a :
Stability Officer – 9-month mission
Your mission
Support the stability program for marketed products, active substances and medical devices that are manufactured on the site : lead annual stability, post approval stability, post approval change stability, registration stability, reworked batch stability testings and annual validation stability studies.
Your responsibilities
- Elaborate and conduct stability program according to the ICH and regulatory requirements
- Contribute to stability results approval
- Lead investigation and manage OOS, OOT, Change Control & CAPA
- Ensure properly escalation of critical quality events to the escalation manager, stability manager and QA Head
- Ensure that stability activities documentation is updated (SOPs, protocols, reports, CMC document, trends….) and that it fits regulatory and QMS requirements
- Work with Regulatory departments as well as external suppliers
- Support continuous KPIs update related to stability activities
- Support stability chambers management on the site, as department owner
- Ensure stability samples management: reception from manufacturing area, labelling prior initiation, entry and exit from stability chambers, distribution to the QC laboratory, destruction and inventory
- Respect all GMP standards. Ensure that operations and documentation meet all cGMP requirements
Your profile
- Bachelor or Master in Chemistry, or related science
- Minimum a 3-year experience in pharmaceutical company in a production or quality environment
- Fluent in French, good level in English
- Proven ability to work with flexibility in a changing and demanding environment
Your application
Please apply on-line. For more information, contact Ms Sophie Darthenay on
For our client, GSK, localized in Nyon in Switzerland, we are looking for a 9-month mission a :
Stability Officer – 9-month mission
Your mission
Support the stability program for marketed products, active substances and medical devices that are manufactured on the site : lead annual stability, post approval stability, post approval change stability, registration stability, reworked batch stability testings and annual validation stability studies.
Your responsibilities
- Elaborate and conduct stability program according to the ICH and regulatory requirements
- Contribute to stability results approval
- Lead investigation and manage OOS, OOT, Change Control & CAPA
- Ensure properly escalation of critical quality events to the escalation manager, stability manager and QA Head
- Ensure that stability activities documentation is updated (SOPs, protocols, reports, CMC document, trends….) and that it fits regulatory and QMS requirements
- Work with Regulatory departments as well as external suppliers
- Support continuous KPIs update related to stability activities
- Support stability chambers management on the site, as department owner
- Ensure stability samples management: reception from manufacturing area, labelling prior initiation, entry and exit from stability chambers, distribution to the QC laboratory, destruction and inventory
- Respect all GMP standards. Ensure that operations and documentation meet all cGMP requirements
Your profile
- Bachelor or Master in Chemistry, or related science
- Minimum a 3-year experience in pharmaceutical company in a production or quality environment
- Fluent in French, good level in English
- Proven ability to work with flexibility in a changing and demanding environment
Your application
Please apply on-line. For more information, contact Ms Sophie Darthenay on