Quality Assurance Auditor

☞ PharmiWeb.Jobs

Ver: 174

Dia de atualização: 29-03-2024

Localização: Lucerne Luzern LU

Categoria: Segurança de qualidade / Controle de qualidade

Indústria: Research Services Biotechnology Research Pharmaceutical Manufacturing

Posição: Associate

Tipo de empregos: Full-time

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Conteúdo do emprego

The Life Science Career Network CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes.

Quality Assurance Auditor

Our Client is an innovative R&D Biotech that has many agents at various trial phases and successfully achieved FDA Approval in 2015 for a new medical device within Oncology. They have a start up feel about them, which creates a fast-paced, highly dynamic and entrepreneurial culture with an emphasis on being patient centric. They went “live” in 2015, so they are still setting and building up the structures and processes and are now in a role out phase for their new product. They are looking for an Auditor Clinical Quality Assurance for a permanent position, to be based in the Lucerne area�

Purpose: provide GCP consultancy to stakeholders and implement Clinical QA oversight by integrating Clinical operations into Quality system. Manage QA audits in order to assure compliance with company SOPs, study protocols, GCP guidelines, relevant regulations and EN ISO 14155 requirements.

Main Responsibilities
  • Develops Quality Management System – focusing on implementing Clinical operations into QMS;
  • Effectively plan and perform regular and random QA audits of clinical trials including but not limited to investigator site audits, vendor audits, internal audits in order to assure compliance with
  • SOPs, study protocols, ICH GCP guidelines, relevant regulations and EN ISO 14155 requirements;
  • Support project audit management and staff training and contribute to the review of QM systems and procedures as appropriate;
  • Participate in Inspection Readiness activities, Regulatory inspections and external audits;
  • Manage and maintain databases for the quality system;
  • well versed and have excellent knowledge of all relevant company SOPs, ISO requirements and appropriate regulations and guidelines.;
  • Evaluate/Manage quality issues, CAPAs, and complaints;
  • Ensure audit results are formally recorded and reported and that corrective/preventive actions are properly completed and documented;
  • Assist with the development of project audit procedures.
Qualifications And Experience
  • Relevant Swiss working/residency permit or Swiss/EU-Citizenship required;�
  • Min 5 years of Clinical Quality Assurance experience in a Pharmaceutical, preferable in a Medical Device regulated environment
  • Degree in Medicine, Technical/Scientific Studies, or equivalent
  • Proven Auditing experience and experience with regulatory inspections and Knowledge of regulations for Medical Devices, especially EN ISO 14155, ICH-GCP
  • Fluent English is a must-have, German is an asset
  • Excellent written and oral communications
  • Willingness to travel at least 40% of time (international and domestic)
Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the ’apply now’ button, or write an email to us, or reach out to us on the phone.
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Data limite: 13-05-2024

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