Job Opportunity:
A critical validation specialist is required to ensure the validation activities associated with a Syringe Filling Line are in compliance with Good Manufacturing Practices and quality requirements.
Key Responsibilities:
* Generate, execute, review and approve commissioning qualification verification test documentation for a Syringe Filling Line.
* Pre-approve and post-approve validation protocols.
* Collate and report on relevant validation data/metrics.
* Assist in exceptions and deviation resolution and root cause analysis.
* Review validation planning documents detailing overall strategy for the project.
* Approve qualification summary reports and generate validation summary reports.
Required Skills and Qualifications:
* 6+ years experience in engineering or validation with a technical qualification at third level or equivalent in engineering.
* Extensive knowledge and demonstrated experience executing validation activities for pharmaceutical/biotechnology projects.
* Knowledge of safety and GMP requirements.
* Demonstrated strong communication skills.
* Experience using paperless qualification systems is preferred.
Benefits:
Join our team of skilled professionals and take advantage of opportunities for career growth and development.
About Us:
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