QA Specialist – 5417 ADA

Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a Quality Assurance Specialist for a 1-year contract, with possible extension, based in the Valais area, Switzerland.


Main Responsibilities:

      Monitoring, trending, reviewing of compliance critical functions including quality systems, change control, training, internal audit, document control, deviation, corrective and preventive actions, regulatory and customer audit program for the site.

      Monitor Quality Performance and trends Quality Events of the site.

      Work with the Compliance Lead and other Department Managers to ensure timely closure of all quality events such as change controls, non-conformances, investigations, corrective / preventive actions (including audit commitments), and effectiveness checks.

      Analyse and present Quality related metrics reports, data and Key Performance Indicators (KPIs)

      Investigate non-product related non-conformance with the required personnel / department on site to develop CAPA and effectiveness checks.

      Frequent review into the Quality Events to ensure the Quality Events are completed to the level as required.

      Participate in the Quality Risk Management Program and Assessment. Work with the Quality Risk Management team to develop Quality Risk Assessment Reports

      Work with the Compliance Lead to evaluate new Global Quality Standards and implement locally where appropriate.

      Participate in the internal audit programs as internal auditor, when required.

      Provide training in key areas of Quality System performance and compliance to continuously improve overall knowledge of the site in quality systems and develop behaviors that contribute to GMP activities.

      Maintains the GMP documents in the Documentum in a GMP compliant manner.

      Communicate potential quality risks / issues based on trends / observations to the management team.

      Support in the Development and maintenance of Department Policies, SOPs, and other documents to ensure compliance to client’s Global Quality Standards

      Work with team members and department managers to evaluate and identify gaps on regulatory guidelines.

      Identify improvement opportunities in the Quality Compliance related areas.

Qualifications and Experience:

  • Relevant Swiss working/residency permit or Swiss/EU-Citizenship required;
  • Direct QA commercial drug substance/drug product experience required.
  • GMP compliance knowledge preferred.
  • Excellent written and oral communication to include accurate and legible documentation skills; ability to work in a fast-paced environment; team oriented; independent work skills and a strong work ethic.
  • The ability to interface and communicate directly with clients is required.
  • Microsoft Office and database management skills, organization skills, record keeping skills and ability to handle multiple projects.