Cleaning Validation Executor (Contractor)
Department: QA Validation
Location: Raheen, Limerick
Responsibilities:
* Collect cleaning validation samples during upstream/downstream processes.
* Collaborate with manufacturing to ensure proper CIP/SIP processes, dirty hold times, and sampling schedules.
* Maintain a consistent and focused approach to tasks.
* Demonstrate strong interpersonal and communication skills.
* Apply aseptic techniques and adhere to ISO7/ISO8 gowning requirements.
* Generate and execute validation protocols and reports.
* Identify and implement continuous improvement initiatives.
* Conduct and assess cleaning validation studies and address related issues during runs.
* Perform technical writing for deviations, change controls, and reports.
* Manage large-scale programs with effective project management skills.
* Understand manufacturing, cleaning validation processes, and related equipment functionality.
* Conduct baseline studies for new equipment and perform coverage testing and clean-into-service activities.
* Maintain and update the Cleaning Validation Plan.
* Schedule and coordinate cleaning activities with manufacturing teams.
* Liaise effectively with cross-functional departments.
* Ensure training compliance and maintain up-to-date records.
* Follow all EHS and safety policies and SOPs.
Requirements:
* Extensive experience in QA validation activities, particularly cleaning validation.
* Proficient in executing cleaning validation protocols.
* Skilled in writing and approving deviations and GMP documentation.
* Strong technical writing abilities for site reports.
* Project management experience is advantageous.
This role requires a hands-on approach, technical expertise, and strong collaboration skills to support and enhance cleaning validation activities.
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