- FR
Investigations Specialist - Biotech (F/M)
Investigations Specialist - Biotech (F/M)
About the role
To join our Life Sciences team in Lausanne, we are looking for an 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.
Your profile
- 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.
About Antaes
Founded in 2007, Antaes is a Swiss management and technology consulting company ranked among the top 15 consulting firms in Switzerland. We employ over 300 experienced consultants who share our passion.
With offices in Switzerland, Singapore, Hong Kong and France, we support our Swiss and international customers at clients in the following areas:
- Organization and transformation consulting
- Industrial Engineering
- Information Systems Management
By joining our teams you will discover :
- A dynamic team in a start-up spirit
- Human support and career development monitoring
- Challenges to help develop your network
- Events: team building, meet-up, workshop, Winter Event ...
-
An @HappyAtWork certified company with a committed CSR policy (Ecovadis2023 Gold Medal)
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Investigations Specialist - Biotech (F/M)
About the role
To join our Life Sciences team in Lausanne, we are looking for an 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.
Your profile
- 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.
About Antaes
Founded in 2007, Antaes is a Swiss management and technology consulting company ranked among the top 15 consulting firms in Switzerland. We employ over 300 experienced consultants who share our passion.
With offices in Switzerland, Singapore, Hong Kong and France, we support our Swiss and international customers at clients in the following areas:
- Organization and transformation consulting
- Industrial Engineering
- Information Systems Management
By joining our teams you will discover :
- A dynamic team in a start-up spirit
- Human support and career development monitoring
- Challenges to help develop your network
- Events: team building, meet-up, workshop, Winter Event ...
-
An @HappyAtWork certified company with a committed CSR policy (Ecovadis2023 Gold Medal)
