QA Senior Expert

vor 4 Wochen


Neuchâtel, Schweiz Randstad (Schweiz) AG Vollzeit
Jobdescription

For our client, an international company based in Neuchâtel, we are looking for a QA Senior Expert.

General Information:

  • Start date: 01.01.2025

  • End date: 31.07.2025

  • Workplace: Neuchâtel

  • Workload: 100%

Tasks and responsibilities:

  • Responsible for Quality Assurance in the frame of activities all along the manufacturing and release process.

  • Responsible for compliance and quality oversight related to activities throughout the manufacturing and release process of bulk drug substance (BDS).

  • Representative for both routine GMP (Good Manufacturing Practices) activities as well as for all improvement projects for the site

  • Ensure the quality of information reported within the various systems and documentation with respect to current guidelines, compliance and regulatory requirements.

  • Participation in GMP zone audits as well as internal and external regulatory inspection

  • Accountable for the promotion of continuous improvement and involved related initiatives.

  • Understand and apply EHS guidelines and commitments policy, take care of its own safety, report risk situations and improvement opportunities to supervisory personnel.

  • Can act as back up of other QA Senior experts and QA Lead as requested.

Your profile:

  • At least 3 years of experience in an GMP environment

  • University degree in Engineering, Biotechnology, Pharmacy or Quality Management applied to industrial process or equivalent experience in pharmaceutical and /or biotechnological companies

  • Knowledge or experience in bulk drug substance (BDS).

  • Fluent French and a good command of English

  • Good knowledge of FDA, EMA, ICH regulations, Pharmacopeias and Quality system standards

  • Knowledgeable in auditing and inspection against regulatory / Quality standards

  • Knowledge/Experience with Quality tools such as Trackwise

  • Good analytical skills and ability to simplify the complex

  • Solution oriented and team spirit

  • Good listener and communication skills

  • Good organizational skills and continuous improvement mindset

Lucie Nasshan
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