Stability Officer

☞ GSK

Visualizza: 158

Giorno di aggiornamento: 25-04-2024

Località: Nyon Vaud VD

Categoria: Garanzia di qualità / Controllo di qualità Produzione / Funzionamento Merchandising / Acquisti / Catena di fornitura

Industria: Pharmaceutical Manufacturing

Tipo di lavoro: Full-time

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Contenuto del lavoro

Site Name: Switzerland - Nyon

Posted Date: May 25 2022

Are you energized by a Stability officer role that allows you to support the stability program for marketed products, active substances and medical devices that are manufactured on the site: lead annual stability studies, post approval stability, post approval change stability, registration stability, reworked batch stability testing and annual validation stability.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
  • Elaborate and follow the stability program according to the ICH and regulatory requirements
  • Prepare protocol/report stability as author
  • Contribute to the approval of stability results
  • 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 up to date of the documentation related to stability activity (SOPs, protocols, reports, CMC document, trends….) and its compliance regarding regulatory and QMS requirements
  • Work with Regulatory and Technical departments as well as liaising with external suppliers
  • Support continuous up to date KQIs related to stability activity
  • Support the management of the climatic chambers on the site, as department owner
  • Support the stability sample management, reception from manufacturing area, sample labelling prior start, loading and exit from stability chambers, distribution to the QC laboratory, destruction and inventory.
  • Respect all GMP standards. GMP knowledge and experience to support the requirements expected by Swissmedic, European union agencies and other regulatory bodies to assure that our products meet all cGMP requirements together with our operations and documentation system.
Why you?

Basic Qualifications

We are looking for professionals with these required skills to achieve our goals:
  • A degree in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent degree
  • 3-6 years’ experience
  • Good knowledge of GMP and regulatory expectations
  • French (fluent) and English (B2/professional)
  • MS office/SAP/LIMS/EMPOWER
Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

As GSK Focuses On Our Values And Expectations And a Culture Of Innovation, Performance, And Trust, The Successful Candidate Will Demonstrate The Following Capabilities

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.
  • Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Continuously looking for opportunities to learn, build skills and share learning.
  • Sustaining energy and well-being Building strong relationships and collaboration, honest and open conversations.
  • Budgeting and cost-consciousness
  • This is a job description to aide in the job posting, but does not include all job evaluation details.
  • Li-GSK
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK’s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.
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Scadenza: 09-06-2024

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