Preparation and support execution of validation protocols according to the Validation masterplans and schedule in Computer Systems Validation. Support improvement projects with technical input and participating in problem solving teams.
Skills, Experience, and Education Required
- Minimum degree level qualification in relevant life science or equivalent.
- Good knowledge of current GMP requirements for validation in the EU
- Good communication skills
Key Responsibilities and Duties
- Coach the implementation teams in the proper execution of validation documents
- Evaluate proposed changes to validated computer systems and recommend level of validation activities required
- Coordinate audits of internal computer systems validation activities, protocol, and procedures, and prepare responses
- Identify and qualify all computer systems which impact cGMP operations using a risk-based methodology
- Develop CFR Part 11 computer systems validation plans, qualifications test protocols, traceability matrices, reports, IQ/OQ protocols and all documents, and deliverables within the scope of the validation plan
- Develop and maintain test plans, test scripts and user acceptance tests and manage the execution of test plans
- Act as a CSV Lead for all validation projects
- Execute or oversee the execution of validation plans and validation documents
- Perform project management activities for CSV process within the scope of an overall system project
- Work with overall project manager to include validation activities in implementation timelines
- Manage internal CSV resources to facilitate completion of qualification activities
- Ensure initiation/preparation and closeout of all CSV related deviations, discrepancies and change control documents.
- Work closely with Validation Manager and QA Compliance to ensure appropriate validation of cGMP computer systems
- Conduct or facilitate validation and 21 CFR Part 11 training
This company is currently going through a period of growth and about to go on a really exciting journey, there is lots of potential at this business and I would highly recommend applying for this role!
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