Description
Project Manager TRD QA DSMStart date: asap
FTE: 100% role
Length of assignment: planned for 1 year
Department: TRD QA DSM
Basel, Switzerland
Our client, one of the leading pharmaceutical and chemicals companies in the world is currently seeking a TRD QA DSM Project Manager to assist the team.
Major Activities
? Managing portfolio of projects, supporting a discipline and provide a service. If applicable, may provide functional expertise in area of responsibility.
? Review and recommend disposition of deliverables (e.g. procedures, records, third party work, contractors, clinical trial material, components) and related tools (e.g. IT, document systems, training tools, facility validation) to ensure GMP compliance. With training and specific delegation may also approve relevant deliverables.
? Support project related activities
(e.g. interpret results, evaluate data, draw relevant conclusions).
? Write GMP relevant documents in own area of responsibility
(e.g, SOPs with global applicability).
? Provide support to TRD line functions in GMP compliance related issues
(e.g. training, document management) .
? Meet internal and external guidelines regarding quality and safety (quality manuals, regulatory cGMP guidelines, health authority guidances, SOPs, HSE, etc). Promote and enforce compliance to guidelines.. If managing associates, ensure same for them.
Your Profile
? Technician with continuing education (EU) or BS/MS (US) or equivalent. Basic degree in scientific or relevant discipline (BS or equivalent). Or advanced degree in scientific or relevant discipline
? Good ability to analyze and evaluate GMP compliance
? Ability to negotiate and communicate.
? Sound scientific, technical and regulatory knowledge in a specific area.
? Very good knowledge of cGMPs, working knowledge of safety and environmental regulations and guidelines
? Good knowledge of drug development .
If you are planning your next step in your career in Switzerland, please contact Sabina Keel at Real Staffing on or to find out more about this opportunity.
Real Staffing
Sabina Keel