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Archiviertes Projekt - Validation Expert NOVJP00028432 (m/f) 393053/29

Dezember 2018

Dezember 2019


nicht angegeben




Ihre Aufgaben:
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
Contribute to risk assessments for CPV
Set local procedures and templates for respective validation processes, documentation and validation master plan, create assessments on component criticality
Maintain all responsible activities and projects in an inspection ready status ahead of any internal or external audits to ensure successful inspections e.g. no critical observations related to validation activities
Lead, facilitate, elaborate and author risk assessments for validation together with the site validation team (PU, QC, QA ) and external functions (TRD, DRA)
Ensure 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
Author and review process, packaging or cleaning validation protocols (e.g. launches, transfers, weak point remediation) and related reports, propose and review MBRs and associated change controls
Support 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
Participate in transfers and launches, contribute to provide experimental data obtained during the validation activities which will be used to prepare the related registration documentation (e.g. P35 module)
Support successful Handover, Submission and Launch with no delay of approval due to PAI or technical issues related to NTO
Contribute or write, review and revise any SOPs related to validation activities, provide guidance to facility impact and component criticality assessments

Ihre Qualifikationen:
BSc. in Chemistry, Pharmacy, Chemical Engineering or Pharmaceutical Technology
Fluency in English and in local language
Profound 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)
Fundamental understanding of standard pharmaceutical analytical testing

Projektstart: asap
Projektdauer: 12 MM++

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