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Quality assurance specialist

Cork
beBeeValidation
Quality assurance specialist
Posted: 16 September
Offer description

Validation Engineer

We are seeking a skilled professional to join our organization as a Validation Engineer. This key role involves participating in the development, commercialization and implementation of innovative medicines and antiviral drugs used in the treatment of various diseases.

The primary responsibilities of this position include:
* Creation of validation impact assessments (VIA) for new equipment and processes.
* Review and approval of change controls.
* Development of process validation plans and cleaning validation plans.
* Updating of cleaning validation and process validation documentation.
* Cleaning technical assessments.
* Process flow mapping of products and equipment.
* Generation of process performance qualification (PPQ) and process validation (PV) protocols.
* Execution of PPQ/PV activities.
* Training on PPQ/PV protocols.
* Generation of PPQ and PV reports.

Requirements:
* Excellent analytical and problem-solving skills.
* Strong understanding of GMP regulations and industry standards.
* Effective communication and training skills.

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