Antaes Consulting SA | Investigations Specialist
4 weeks ago
Investigations Specialist - Biotech (F/M)
To join our Life Sciences team in Lausanne, we are looking for a
Investigations Specialist (F/M)
in the biotechnology sector.
The purpose of this role is to manage deviations occurring in the different manufacturing suites (USP and DSP), for the different products within quality system (i.e. Trackwise) in a timely manner.
Perform evaluations related to impact on concerned equipment/product/material with the support of relevant experts,
Perform root cause investigations using Six Sigma methodologies (DMAIC, Ishikawa diagram, 5M, contradiction matrix, etc.), including ability to collect and analyze data in the different automated systems and on-the-floor (regular GEMBA),
Identify and implement relevant corrective and preventive actions (CAPA), including business case and planning preparation with relevant stakeholders,
Write investigation and impact assessment reports in a comprehensive and scientific format,
Present report-out and/or escalate blocking points to line Manager,
Monitor and control internal deviations and CAPA KPI in concertation with line Manager,
Depending on deviation complexity, lead cross-functional investigation team including workshop or brainstorming sessions.
Minimum Requirements:
Bachelor/Master in Engineering field (chemical, biotechnology) or equivalent,
3-5 years of experience within a biotech/pharmaceutical GMP manufacturing environment,
Strong knowledge and interest in biotechnological processes (USP and/or DSP),
Good knowledge of cGMP and associated regulations,
Ability to describe complex technical processes or problems into simplified and concise reports,
Ability and appetence for working cross-functionally, interacting daily with various stakeholders (Manufacturing personnel on the floor, MSAT, QA, QC, Engineering, EHS, etc.) in a team-based culture,
Fluent in French and English.
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