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Recruitment Specialist @ Arcadis DPS Group
CSV Specialist
Purpose and Scope:
Reporting to the Lead, Pharma Manufacturing Quality Services Dublin, the CSV (Computer System Validation) Specialist will manage the validation of GxP computerized systems, including the preparation of validation documentation and execution of required testing.
Responsibilities and Accountabilities:
* Project management and execution of qualification activities related to GxP computerized system validation.
* Support project planning and real-time status reporting of GxP computerized system validation project deliverables.
* Preparation, review, and approval of validation documentation, including validation plans, protocols, reports, risk assessments, etc.
* Support the closure of deviations initiated during qualification/validation activities, including performing troubleshooting as required.
* Support the validation periodic review process.
* Ensure data integrity requirements are being met across the validation lifecycle for all system documentation.
* Responsible for meeting regulatory requirements for GxP computerized system validation, e.g., FDA 21 CFR Part 11, Annex 11, GAMP 5 guidelines, etc.
* Ensure compliance with relevant regulations and standards associated with ISO 14001, ISO 45001, Health & Safety Legislation, Environmental Legislation, and all site standards, policies, and procedures.
Required Qualifications:
* Educated to degree level in a scientific/engineering discipline.
* Extensive experience working in a GMP environment.
* Extensive knowledge of validation requirements relating to GxP computerized systems.
* Able to work effectively using own initiative, be a good communicator, and have the ability to work well in a team environment.
Preferred Qualifications:
* Manufacturing site-based experience working in a cGMP environment, preferably with some computer system validation experience on Manufacturing Execution Systems (MES).
* Solid problem-solving skills.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Information Technology and Project Management
Industries
Pharmaceutical Manufacturing
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