Overview
Reporting to the Engineering department, this role will support delivery of the Site Validation Master Plan (SVMP) Schedule, overseeing validation/ qualification activities across the Jazz KSP site including manufacturing plant equipment, laboratory analytical equipment and utility/ facility qualification, ensuring compliance with Jazz procedures, Regulatory requirements and GMP (Good Manufacturing Practice).
Essential Functions/Responsibilities
* To generate validation/ qualification documentation (following Jazz templates/ procedures) associated with manufacturing plant equipment, laboratory analytical equipment and utilities/ facilities across commercial and development space. This will include routine requalification works (as per periodic evaluation of systems) as well as introduction of new equipment (supporting Capital Project team).
* If a vendor is authoring validation documentation (e.g. FAT, SAT, IQ etc), to review / approve documentation.
* To lead/ support execution of validation/ qualification activities in collaboration with system owning department.
* Visit equipment vendor facilities to execute FAT (Factory Acceptance Test) as required.
* Manage activities as per the SVMP and report progress via the SVMP.
* Manage third party suppliers with respect to qualification and validation activities (where required).
* Provide SME impact assessments for change controls involving validation/ qualification activities.
* Own and deliver Change Actions and CAPAs within eQMS for validation/ qualification activities.
* Lead deviations related to qualification incidents.
* Support equipment decommissioning activities as required.
* Matrix manage teams as required to deliver a validation project.
Required Knowledge, Skills, and Abilities
* 5+ years relevant work experience in the pharmaceutical, biotechnology or related industry where principles of GMP apply
* An appreciation of validation principles
* Experience in technical writing, and good knowledge of Microsoft Office IT packages (Word, Excel, Powerpoint).
* Ability to collaborate across cross functional teams, and matrix manage teams for delivery of a validation project.
* Excellent communication skills
Required/Preferred Education and Licenses
* A bachelor’s degree in science, engineering or related discipline (preferred)
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