Our customer, a pharmaceutical company near Basel, needs reinforcement. For a temporary employment we are looking for a
Validation Expert, 100% (f / m)
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
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
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
BSc. in Chemistry, Pharmacy, Chemical Engineering or Pharmaceutical Technology
Fluent in English and in local language
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)
Fundamental understanding of standard pharmaceutical analytical testing