Qa Validation Consultant

QA Validation Consultant/Technical Writer Summary: We are seeking an experienced QA Validation Consultant with a background in validation activities and technical writing. This role is responsible for managing and executing validation protocols, writing and approving deviations, and ensuring compliance across processes. The ideal candidate will have expertise in CIP/SIP validation, cleaning validation, and project management.

Key Responsibilities: Execute and oversee cleaning validation and CIP/SIP validation protocols. Write and approve GMP documents, deviations, and investigation reports. Conduct and review validation study assessments, especially CIP/SIP outcomes. Generate, review, and approve CIP/SIP protocols and related summary reports. Schedule and coordinate cleaning/SIP activities with manufacturing teams. Collaborate with cross-functional departments and ensure quality standards are met. Continuously monitor and improve validation processes while adhering to safety policies. Required Experience: Strong technical writing skills, with experience generating site reports. Proficiency in validation, especially CIP/SIP, and quality assurance. Demonstrated project management abilities in overseeing large programs. Familiarity with manufacturing and CIP/SIP equipment operations. Proven ability to work independently with excellent communication and interpersonal skills. Knowledge of EHS and continuous improvement processes.
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