Computer Systems Specialist - Eurofins CDMO Alphora Inc
Computer Systems Specialist - Eurofins CDMO Alphora Inc
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Salary Not Disclosed
1 Vacancy
Job Description
- Primary IT contact / Subject Matter Expert to ensure Laboratory Computerized Systems and Computerized Systems supporting Operations Equipment (i.e. Computerized Systems) are installed qualified/ validated and maintained in accordance with inhouse procedures and regulatory standards (e.g. cGMP GAMP 5 21 CFR part 11 suitable for the equipments intended use
- Support the acquisition configuration and installation of Computerized Systems
- Support the development of Risk Assessments and User for new and modified Computerized Systems
- Obtain vendor specifications for assessment against URS compliance Eurofins IT and other integration applications
- Ensure URS and Risk assessment of systems before purchase work with IT to prepare for approvals with Eurofins
- Support Eurofins IT Form application submissions
- Support the development of Qualification / Validation Protocols and Reports for new and modified Computerized Systems
- Responsible for of the IT portion of Computerized Systems Qualification / Validation Protocols including solving problems and addressing discrepancies identified during
- Assist in the development of Standard Operating Procedures related to usage and maintenance of Computerized Systems
- Develop execute and maintain assigned IT Preventative Maintenance (PM) tasks for Computerized Systems
- Support Laboratory Management with the general maintenance troubleshooting and repairs of Laboratory Computerized Systems including interactions with thirdparty vendors as required
- Support Operations Management with general maintenance troubleshooting and repairs of Computerized Systems supporting Operations Equipment including interactions with thirdparty vendors as required
- Support the evaluation of proposed changes to Computerized Systems including the writing and of Change Controls as required
- Support qualification and startup activities for new Biologics business unit
- Maintain documentation in accordance with Good Documentation Practices
- Training of Staff on the use of equipment as needed.
- Collaborate within IT other departments (e.g. QA Engineering corporate IT) and external vendors
Qualifications :
- Education: Bachelors degree in business/technical area or comparable education/experience.
- 5year min experience in Computer Systems Validation within the pharmaceutical / biotechnology GMP environment including authoring and of IQ/OQ/PQs experience in performing traceability matrices risk assessments is preferred
Must have a collaborative mindset and be a selfstarter - Strong oral/written communication skills
- Strong technical writing abilities required to draft SOPs and PMs
- Strong technical skills in handson configuration of a variety of Laboratory systems (ie. Mass Spec IC Matersizer UV FTIR DSC etc.
- An advanced understanding of security of data systems for the protection of electronic assets intellectual property and privacy.
- Experience in developing and implementing complex data exchange technology processes between information systems.
- Experience in creating/developing a moderate to complex functional requirement mapping to an Information System based on business requirements.
- Ability to independently identify compliance risks and escalate when necessary.
To learn more about CDMO visit the website at Information :
At Eurofins we offer excellent fulltime benefits including health & dental coverage life and disability insurance RRSP with 3 company match paid holidays paid time off.
Accommodation: Persons with disabilities who need accommodation in the application process or those needing job postings in an alternative format may email a request via the website at .
As a Eurofins employee you will become part of a company that has received international recognition as a great place to work. To learn more about Eurofins please explore our website at
We thank all applicants within commuting distance of GTA Ontario for showing an interest in this position. Only those selected for an interview will be contacted.
This posting is supported by AI technology to assist in screening candidates and resumes.
NO AGENCIES CALLS OR EMAILS PLEASE
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
