QA Senior Expert
Updated: 12 Dec 2024
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 (od 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
- Kledge or experience in bulk drug substance (BDS).
- Fluent French and a good command of English
- od kledge of FDA, EMA, ICH regulations, Pharmacopeias and Quality system standards
- Kledgeable in auditing and inspection against regulatory / Quality standards
- Kledge/Experience with Quality tools such as Trackwise
- od analytical skills and ability to simplify the complex
- Solution oriented and team spirit
- od listener and communication skills
- od organizational skills and continuous improvement mindset