QA Senior Expert.

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