Permanent CSV opportunity within a highly regulated environment
This is an excellent permanent opportunity for a skilled individual in the area of CSV. The successful individual will have a significant role in the validation of Computerised Systems. This person will contribute to the development of custom programs, as well as configurable off the shelf systems. Key responsibilities include ongoing evaluation and periodic review of existing validated computer systems; change control. Other responsibilities of this position include generation and execution of validation deliverables and life cycle documents.
- Develops and executes all validation deliverables including execution for:
- Automation Projects - OSI PI upgrade / Integrations, Version dog 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
- Computer Science or Engineering/Science Degree is preferred.
- 5+ years' experience in Bio-Pharmaceutical or equivalent type life science industry.
- Must possess a thorough understanding of GxPs, in addition to FDA and International requirements for computer validation and Part 11 / Annex 11 requirements.
- Must have good interpersonal and communication skills - the position will require a good deal of interdepartmental interaction and coordination.
- 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, Power Point).
- Experience with HP ALM or equivalent software testing/requirements tools.
If you are interested in the above opportunity, or would like to find out more then click the 'apply now' button or get in touch today on 021 2300 300 or email Kellie on firstname.lastname@example.org
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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