Quality Assurance Associate

Highly Competitive
  1. Contract
  2. Good Manufacturing Practice (GMP), Good Clinical Practice (GCP)
  3. Switzerland
Solothurn
Posting date: 27 Mar 2019
QA.CM.22389_1553701673

ProClinical is partnering with a with a large global biotechnology company to advertise a vacancy for a Quality Assurance Associate position. The organisation, which develops innovative therapies for neurological diseases and delivers biological products, is seeking for the Quality Assurance Associate to join their office in Switzerland. This is an exciting opportunity for an experienced and motivated applicant to develop a career in a truly revolutionary field.

The Senior Associate will support the quality management system on review and approve validation and engineering documents, test protocols, CAPAs, deviations, change controls, and any technical documentation where QA needs to approve before implementation and upon completion. Furthermore, they will advise the project groups as appropriate and be an active member of the groups where the quality input is needed.

Job Responsibilities:

  • QA oversight with respect to QE tasks:
    • Qualifying and Validating
    • Adapting and implementing procedures.
    • Fostering continuous improvement.
    • Overseeing Engineering and Automation.
  • Reviewing GMP documents and raw data for compliance to applicable regulatory and corporate guidance documents, such as CAPAs, deviations, operational procedures, etc.
  • Reviewing and approving change control documents and activities associated with change control implementation.
  • Keeping up to date on cGMPs and regulatory requirements, as well as global procedures, guidelines, and policies.
  • Proactively identifying and proposing resolutions to both technical and compliance issues/gaps, as well as developing and implementing Quality Systems.
  • Collaborating with every level of the organisation and multiple functions, including engineers, Manufacturing personnel, SMEs on equipment, and knowledge of the biotechnology API production.
  • Making compliance decisions about facility, utility, and equipment validation, changes, and deviations, etc.
  • Supporting new employees in skill development.
  • Being responsible for GMP assessment on quality engineering documents.

Skills and Requirements:

  • A relevant degree and demonstrable relevant experience.
  • Fluency in German a useful attribute.
  • Strong working knowledge of cGMP requirements as applicable to drug substance.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Caleb Mensah at +44 203 854 1080 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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