Job Description
Sought after expert to support Computer System Validation at a leading Pharmaceutical company based in Cork, Ireland on a 12-month contract basis.
Key Responsibilities:
* Maintain comprehensive knowledge of relevant policies, procedures, and regulatory standards including 21 CFR Part 11, Data Integrity, and GAMP.
* Perform IQ, OQ, and PQ activities.
* Develop and execute Validation master plans.
* Manage all aspects of Quality Systems Management processes (Change Control, Deviation, Corrective and Preventive Actions) and validate computerized systems.
* Participate in audits and inspections as a Subject Matter Expert.
* Own, revise, and maintain Standard Operating Procedures (SOPs).
* Mentor and train junior team members.
Requirements:
* Degree or Master's in Computer Science, Engineering, or related field.
* A minimum of 3 years' experience in Computer System Validation.
* Preferred experience with CAPAs and deviations.
* Experience working in a GMP environment.
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