Stability Officer

16.09. | Temporary | 100%

Stability Officer

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

16.09.2020
Employee, 100%

Contact

Kelly Services Switzerland

Sophie Darthenay


Kelly Life Sciences

rue du Rhône 114Geneve

Industry

Human resources / Personnel services

Kelly Life Sciences

rue du Rhône 114Geneve

Industry

Human resources / Personnel services
Salary

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