Quality Assurance Specialst
Posted on Mar 24, 2021 by Michael Bailey Associates - Zurich
A new opportunity has been created for a QA specialist to support projects and processes in line with the company standards and GMP compliance.
Manage portfolio of projects, support a discipline and/or provide a service.
Review and recommend disposition of deliverables (eg procedures, records, third party work, contractors, clinical trial material, components) and related tools (eg IT, document systems, training tools, facility validation) to ensure GMP compliance.
Support project related activities (eg interpret results, evaluate data, draw relevant conclusions).
Perform inspections and audits as required
Contribute to the evaluation of new QA tools.
Write GMP relevant documents in own area of responsibility (eg, SOPs with global applicability).
Meet internal and external guidelines regarding quality and safety (quality manuals, regulatory cGMP guidelines, health authority guidelines, SOPs, HSE, etc).
Promote and enforce compliance to guidelines.
education to BS/MS (US) or equivalent Basic degree in scientific or relevant discipline (BS or
1. At least 2 years of relevant experience.
3. Sound scientific, technical and regulatory knowledge in a specific area.
4. Very good knowledge of cGMPs, working knowledge of safety and environmental regulations and guidelines.
5. Good knowledge of drug development.
6. Good organizational skills.
7. Good ability to analyse and evaluate GMP compliance.
The contract is office based in Basel with home/work base flexibility.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.