QA Senior Expert

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p>Start date: 01.01.2025

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p>End date: 31.07.2025

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p>Workplace: Neuchâtel

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p>Workload: 100% 

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p>Tasks and responsibilities:

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

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

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

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

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

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

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

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

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p>Your profile:

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p>At least 3 years of experience in an GMP environment

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

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p>Knowledge or experience in bulk drug substance (BDS).

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p>Fluent French and a good command of English

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

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p>Knowledgeable in auditing and inspection against regulatory / Quality standards

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p>Knowledge/Experience with Quality tools such as Trackwise

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p>Good analytical skills and ability to simplify the complex

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p>Solution oriented and team spirit

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p>Good listener and communication skills

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p>Good organizational skills and continuous improvement mindset