Archiviertes Projekt - Validation Expert
Firmenname für PREMIUM-Mitglieder sichtbar
* Leads, facilitates, elaborates and authors risk assessments for validation together with the site validation team and external functions
* Ensures that all respective validation activities are in line with the current requirements and cGMP, handling any deviations associated to these activities including oversight of prevalidation and validation resulting from launch projects as well as major or complex changes.
* Authors and reviews process, packaging or cleaning validation protocols (e.g. launches, transfers, weak point remediation) and related reports, proposes and reviews MBRs and associated change controls. Supports the execution at the shop floor.
* Responsible to translate the critical process parameters and the process control strategy into a focused validation plan for process validation.
* Participates in transfers and launches, contributes to provide experimental data obtained during the validation activities which will be used to prepare the related registration documentation. Supports successful Handover
* Contributes or writes, reviews and revises any SOPs related to validation activities, provide guidance to facility impact and component criticality assessments. Provides input to Quality Manuals (QM)/Quallity Directives (QD)/global Standard Operating Procedures (SOPs) and Guidance Documents to ensure the document is in line with global/local requirements and industry standards.
* Provides technical expertise and participates in the improvement and remediation of products in the product improvement portfolio.
* BSc. in Chemistry, Pharmacy, Chemical Engineering or Pharmaceutical Technology.
* Several years experience in manufacturing/ manufacturing science and technology/technical development/Quality.
* Thorough understanding of manufacturing processes and related process equipment.
* Strong working knowledge of quality systems and regulatory requirements across multiple health authorities.
* Experience in executing process validation.
* Expert in reviewing and writing technical reports.
* Proven project management experience in a cross-functional environment.
* Fundamental understanding of standard pharmaceutical analytical
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