Process-oriented visionary wanted!
Our customer, a pharmaceutical company based in Stein/AG, needs reinforcement. For a temporary employment (duration: 10 months) we are looking for a
Validation Expert, 100% (m/f)
- 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 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 etc.
- BSc. in Chemistry, Pharmacy, Chemical Engineering or Pharmaceutical Technolog
- Fluent in English and German
- 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.
… please contact Mr. Renato Imboden by phone on 061 269 90 60