Beschreibung
For our client, a pharmaceutical company in Switzerland, we are looking for a motivated and ambitious:
Senior Computer Systems Validation Lead
Background:
The main focus of this position will be MES (Manufacturing Execution System). In addition there will be topics around Shop Floor Serialization, Data Analytics and Reporting Solutions.
Responsibilities:
- Leads a project stream for validation with the objective to set up the CSV of a MES Program (initial Core validation + rollouts)
- Ensures the completion of CSV deliverables in time and in quality
- Ensures the alignment of the different stakeholders
- Collaborates with and gives regular updates to the Project Manager
- Authors, reviews and consults on validation documentation including but not limited to Test Scripts, Validation Plans, Installation Qualifications, SATs, UATs and Validation Reports
- Ensures compliance with corporate and global internal standards (eg internal CSV policies, directives and SOPs or project management methodology) and legal requirements
- Escalates non-compliance against quality standards to appropriate governance bodies and Risk Management function for resolution
- Provides advice, expertise and trains others in the requirements for Quality Assurance and provides input to Informatics process improvement projects and other cross functional programs
Must Haves:
- Very good understanding of CSV in a pharmaceutical MES (+7 years of work experience in the relevant area)
- Experience in validation for MES projects (+5 years of work experience)
- Ability to communicate clear and effectively
- Ability to arbitrate between a wide range of stakeholders to come to a solution (former work experience with stakeholders would be a big plus)
- Strong leadership skills (former work experience as a lead would be a big plus)
- Fluent in English (written and spoken)
- Flexible for business travels (up to 20%)
Nice to Haves:
+++ Experience in CSV for a global program
+++ Understanding of the MES process
++ German speaking
++ Project management experience
Start date: 13.03.2017
End date: 31.12.2017 (plus possible extension)
Location: Basel area (possibility to work partially remotely)
Are you interested to work in this challenging position? Alessia Biassoli, Talent Resourcer, is looking forward to receiving your complete profile. Please send an e-mail (see below)