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Senior Computer Systems Validation Specialist (MES)
Eingestellt von Coopers Group GmbH
Gesuchte Skills: Client
Projektbeschreibung
For our client, a pharmaceutical company in Basel, we are looking for an experienced and ambitious SENIOR COMPUTER SYSTEMS VALIDATION SPECIALIST (MES).
Background:
We are looking for a Validation Lead who will be working for the Global Solution Center - Manufacturing IT supporting Pharma Global Technical Operations at Kaiseraugst and Basel, Switzerland. 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.
MAIN TASKS & 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 company 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)
- Strong project management skills and delivery focused (+5 years of PM experience)
- 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 an advantage)
- 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
Start date: 04.09.17
END DATE: 31.12.2018 (EXTENSION POSSIBLE)
Work location: Basel area
Are you interested to work in this challenging position?
Alexander Braunagel, Recruitment Executive, is looking forward to receiving your complete profile. Please send an e-mail.
Background:
We are looking for a Validation Lead who will be working for the Global Solution Center - Manufacturing IT supporting Pharma Global Technical Operations at Kaiseraugst and Basel, Switzerland. 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.
MAIN TASKS & 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 company 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)
- Strong project management skills and delivery focused (+5 years of PM experience)
- 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 an advantage)
- 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
Start date: 04.09.17
END DATE: 31.12.2018 (EXTENSION POSSIBLE)
Work location: Basel area
Are you interested to work in this challenging position?
Alexander Braunagel, Recruitment Executive, is looking forward to receiving your complete profile. Please send an e-mail.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung