We are searching for an experienced validation expert to take on a project in cleaning and packaging validation.
• 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 and external functions
• 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.
• 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.
• Contributes or writes, reviews and revises any SOPs related to validation activities, provide guidance to facility impact and component criticality assessments. Provides input to Quality Manuals (QM)/Quallity Directives (QD)/global Standard Operating Procedures (SOPs) and Guidance Documents to ensure the document is in line with global/local requirements and industry standards.
• Provides technical expertise and participates in the improvement and remediation of products in the product improvement portfolio.
• Owns the Training Curriculum for its Job Description and provides the necessary training and support to new associates joining this position.
• university degree in Chemistry, Pharmacy, Chemical Engineering or Pharmaceutical Technology.
• 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
Fluency in English and German language skills
Michael Bailey International is acting as an Employment Business in relation to this vacancy.