Validation Expert

Job description

Job Description

Executing and managing process, primary packaging, and cleaning validation activities and change management activities to meet cGMP requirements on time and quality to ensure that site validation programs are compliant with global regulatory expections.

Stewardship: 
Support Product Steward in maintaining the process control strategy.Translate applicable process parameters and the process control strategy into a focused validation plan for process validation. Provide technical expertise and facilitate establishment of Quality Risk Assessment (as needed). Validation: Support site validation planning by writing and maintaining master plans for processes, cleaning, packaging processes and ongoing verification for processes and cleaning (as applicable). Support process validation lifecycle activities by ensuring a state of control is maintained through ongoing process verification (OPV). Ensure that appropriate variables are identified for on-going monitoring as a contributor to quality risk management activities. Author and review process, packaging or cleaning validation protocols & reports, ongoing process and cleaning verification protocols & reports. Support execution of validation activities at the shop floor. Support validation lead for KPI reporting.  Reviews Master Batch Records and associated change controls. Confirm revalidation need based on technical changes Maintain all activities and projects under own responsibility in an inspection ready status. Provides technical expertise (and may facilitate) pre-validation risk assessments using risk management tools. Work collaboratively and cross functionally to help ensure that process risks are analyzed, appropriately controlled and appropriately documented. Ensure that all Site validation activities are performed and are in line with the current Novartis requirements and cGMP, manage deviations associated with process validation and makes recommendations for deviation resolution as well as prevention of reoccurrence. Launch & Transfer: Work in close collaboration with development organization (or sending site) for technical transfers and new product launches to ensure that knowledge is transferred, control strategies are appropriate, risks are analyzed and controlled and to ensure that commercial processes are validation ready Participate in pre-validation activities and risk assessments to ensure the success of commercial process validation. This position is limited from 08.01.2018 - 14.12.2018

Desired profile

Minimum requirements

BSc. in Chemistry, Pharmacy, Chemical Engineering or Pharmaceutical Technology.
Local language and English fluent
2-3 year experience in manufacturing/ manufacturing science and technology/technical development/quality.  T
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 testin