Beschreibung
Validation Expert: - German and English Required!!!Major Accountabilitie
-Support writing and maintaining Validation Master Plan for process, cleaning and packaging validation.
-Support the strategy for continued process verification (CPV) -and annual monitoring batches that ensures all critical process parameters and quality attributes are defined after validation activities. Contributes to risk assessments for CPV.
-Set local procedures & templates for respective validation processes, documentation and validation master plan, create assessments on component criticality.
Validation activities:
-Leads, facilitates, elaborates and authors risk assessments for validation together with the site validation team (PU, QC, QA ) and external functions (TRD, DRA).
-Ensures that all respective validation activities are in line with the current Novartis requirements and cGMP, handling any deviations associated to these activities including oversight of pre-validation 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 (e.g. P35 module).
Requirements:
* BSc. in Chemistry, Pharmacy, Chemical Engineering or Pharmaceutical Technology.
Languages
* 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 (e.g. multi-site, technical development, other functions).
Michael Bailey International is acting as an Employment Business in relation to this vacancy.