Posted on Jul 21, 2020 by Global Rekrut
- Develops and executes all validation deliverables including execution for:
- Automation Projects - OSI PI upgrade/Integrations, Versiondog Upgrade
- MFG/QC Instruments
- Capable of owning issues/deviations and driving them to resolution.
- Leading testing efforts for small to medium sized projects.
- Reviewing vendor protocols, test scripts, and traceability Matrix.
- Capable of generating test scripts to meet the user requirements.
- Interacts directly with project teams and the associated vendors.
- Responsible assessing the validation impact of changes made to qualified instruments.
- Other duties as assigned.
Skills & Experience Required:
- Good verbal and written communication skills.
- 5+ years' experience in Bio-Pharmaceutical or equivalent type life science industry.
- Good organizational skills.
- Must have good interpersonal skills. Position will require a good deal of interdepartmental interaction and coordination.
- Must possess a thorough understanding of GxPs, in addition to FDA and International requirements for computer validation and Part 11/Annex 11 requirements.
- Must possess a thorough understanding of current industry guidance, including GAMP 5
- Must have direct experience with computer validation and determining computer validation approach.
- Must have ability to comprehend technical information related to computer software, computer and network hardware, and the associated regulatory requirements relating to them.
- Experience/Knowledge in qualifying DeltaV, OSI PI, Serialisation changes.
- Proficiency with MS Office applications (Word, Excel, Visio, Access, Project, Powerpoint).
- Experience with HP ALM or equivalent software testing/requirements tools.
- Computer Science or Engineering/Science Degree is preferred.
*If this role could be of your interest, please submit your CV for immediate consideration. For any questions do not hesitate to contact us*