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Documentation Control Lead IFF (all genders)
Posted 4 hours 8 minutes ago by Sanofi EU
To ensure a rapid processing of your application, please apply only via the "Apply" button. Please include a letter of motivation and a current resume with your application.
About the job
Are you ready to jump into a mega project (> 1 B€ Capex program, thereof design/engineering budget 200 m€), and to bring in your experience & knowledge ?
Your skills could be critical in helping us to achieve our key project milestones. You will lead all Documentation management activities from Basic Engineering until end of Qualification activities in accordance with EHS, Quality, Engineering, Business & Users requirements standard and expectations. Within the IFF project team, and part of our InsuLINK program for insulin drug substance facilities.
We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams.
With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.
Main responsibilities:
To lead the IFF documentation management.
To design detailed approach to manage all documents, based on endorsed strategy on tool and processes.
To coordinate the Sanofi documentation management work with the EPCMCQ engineering contractor for the documentation management topic and all disciplines withing Sanofi IFF organization.
To ensure all documents are managed, identified and stored as per project procedure and global Sanofi procedures.
To ensure all team-mates from IFF team and from EPCMCQ contractor are trained and informed about documentation management
To lead and manage CTOP/VTOP/ETOP preparation and turn-over from vendor/contractor/engineering contractor to C&Q team, and then hand-over between C&Q team and user/ICF.
To provide support to project change, engineering change and technical change assessment with regards to documentation management part.
To collaborate to project meeting.
About you
Experience: Several years of professional experience in managing teams (direct and indirect) in the pharmaceutical industry; Strong experience of pharmaceutical documentation management; proven multi-year experience (>10 years) in the area of project and engineering management; Experience in working in a large, complex matrixes environment with global processes and governance structures; Very good communication and presentation skills; Systematic and structured work style
Soft and technical skills: Good knowledge of FDA/EMA and other regulatory requirements such as cGMP about documentation; Very good knowledge of documentation management in major pharmaceutical capex project
Education: Phd.; Masters degree or diploma in engineering or natural science
Languages: Very good english and germanlanguage skills, both written and verbal
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