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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)

Major accountabilities:

• 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.

Background:

• 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.

For questions

… please contact Mr. Renato Imboden by phone on 061 269 90 60