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

General Information:

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

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

General Information:

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

apply with randstad.
Applying with us is easy. We will review your application and see if you are a good fit for the job and the company.
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Our consultant will call you at a suitable time to discuss your application and further career aspirations.
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compliance, reference and background check.
Next, we just need to verify a few things - we’ll make the relevant compliance checks and and in ensuring you’re perfect for the role, we’ll make contact with any relevant references you’ve provided and will keep you posted.
the perfect job for you.
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QA Senior Expert.

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