Az álláshirdetés lejárt.
Aktuális állást talál az aktív állásajánlatok között: új keresés indítása itt

Stability Manager - Temporary position: 8 Months

Kelly Scientific is looking for the department QA of pharmaceutical company localized in Switzerland a : Stability manager (temporary position of 8 months).

Your mission:
• Manage and coordinate stability activities of products to ensure compliance with the requirements of the internal Quality Manual and all relevant regulatory and legislative requirements.
• Direct and oversee internal and outsourced stability activities.

Your responsibilities:
• Ensure that SOP are in place and that compliance with cGMP is maintained. Ensure the implementation and on-going monitoring of Key Performance Indicators (KPIs) and Key Quality Indicators (KQIs).
• Ensure that the Stability group operates in a cost effective and efficient manner and maintain an innovative approach based on productivity improvement and implementation of best practice.
• Ensure that stability programs are performed using adequate analytical methods : review that analytical methods are adequately developed, validated and maintained.
• Ensure to review the stability part of Product Quality Review reports on time.
• Oversee and direct the analytical method transfer.
• Ensure that adequate and timely analytical support for investigations (e.g deviations, complaints) and troubleshooting is provided to minimize impact on product availability and sales.
• Support the qualification of contract laboratories to monitor and ensure lab compliance with the Internal Quality Manual and applicable regulatory requirements on an ongoing basis
• Assist Quality and Compliance with preparation, management and follow up of Health Authority inspections, as needed
• Review and monitor action plans for correction of audit observations related to the stability programs.
• Utilize active thinking to generate creative solutions to complex technical problems.
• Maintain GMP surveillance on the outsourced stability activities
• Prepare or oversee the preparation of stability documentation (templates, protocols, and reports) necessary to execute the stability studies required to support regulatory variations.
• Ensure that the QA activities related to stability operate in a cost effective manner and maintain an innovative approach based on productivity improvements and best practices.
• Plan and coordinate with primary stability center the stability activities such that method transfer activities are executed, stability samples are provided, and project timelines are met.
• Participate in the management of the analytical method validation plan by highlighting problematic analytical method for remediation at primary contracted stability sites.
• Review and assess analytical methods and provide analytical remediation recommendation.
• Use appropriate QA management tools to monitor and ensure primary external contract lab compliance on an ongoing basis e.g. KPI's
• Actively manage Third Party stability documentation.
• Manage functionally the Stability Specialists.

Your profile:
• Graduate in Analytical Chemistry, Chemistry, Pharmacy, or another related science
• Minimum 5 years of experience in the pharmaceutical industry
• Fluent in French and in English

Your Kelly Contact:
Sophie Darthenay

Recruteur Scientifique
Kelly Scientifique Genève
Region: Vaud
Vertragsart: Befristet
Kategorie: Produktion/Operationen;
Veröffentlicht am: 23.05.14
Beschäftigungsart: Vollzeit (100%)
Job Nummer: JO-1405-8963
Abteilung: Kelly Services, Inc. in Switzerland is a leader in providing innovative workforce solutions. Kelly offers a comprehensive array of custom-designed outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and permanent basis. Kelly provides employment to more than 200 people in over 40 branches and specialist department throughout Switzerland.

Kelly specializes in providing professional/technical workforce solutions, with local expertise. These solutions include Finance, Science, and Medical. Kelly has a rich history in developing our solutions to address the workforce challenges of these communities, with expert staff dedicated to providing integrity and technical competency to ensure high performance, and proven results from its specialty talent.Link megjelenítése" width="0" height="0" />
Munkavégzés helye Not Specified
Kategória Külföldi munka
Régió Külföld
Egyéb hasonló állások Önnek
Belgyógyász állás Németországban


Partnerünk, egy sikeres orvosi karrier-tanácsa...

Villanyszerelő - Raum München

Silverhand Hungary Kft

Jelenleg egy kiemelt partnerünknek keresünk hos...

Targoncavezető - Németország (Landshut, Dingolfing, Elsendorf, Wallersdorf)

Silverhand Hungary Kft

Munkavégzés helye: Németország – Landshut, Ding...