Executing and managing process, primary packaging, 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 expectations.
Validation Master Plan
• Supports site validation planning by writing and maintaining master plans for processes, cleaning and packaging processes (as applicable)
• Supports process validation lifecycle activities for commercial products by ensuring a state of control is maintained through continued process verification (CPV) or annual batch monitoring. Ensures that appropriate variables are identified for on-going monitoring as a contributor to quality risk management activities.
• Establishes local procedures & templates to support validation activities as required. The creation of documentation may extend to pre-validation risk assessment tools and other documented means of managing knowledge.
• Maintains all activities and projects under own responsibility in an inspection ready status to ensure compliant programs successful inspection outcomes.
• Provides technical expertise (and may facilitate) pre-validation risk assessments using risk management tools. Works collaboratively and cross functionally to help ensure that process risks are analyzed, appropriately controlled and appropriately documented.
• Ensures that all validation activities are compliant current Novartis requirements and cGMP. Manages deviations associated with process validation and makes recommendations for deviation resolution as well as prevention of reoccurrence. Provides technical expertise and recommendations for validation of major or complex changes in manufacturing.
• Authors and reviews process, packaging or cleaning validation protocols (e.g. launches, transfers, weak point remediation) and related reports. Reviews MBRs and associated change controls. Supports the execution at the shop floor.
• Responsible to translate applicable process parameters and the process control strategy into a focused validation plan for process validation.
• Participates in Technology Transfer and New Product Launches Works cross functionally to ensure that commercial processes are validation ready. Works in close collaboration with TRD (or sending site) to ensure that knowledge is transferred, control strategies are appropriate, and that risks are analyzed and controlled. Participates in pre-validation activities to ensure the success of commercial process validation.
• Contributes or writes, reviews and revises any SOPs related to validation activities. Provides input to Quality Manuals (QM)/Quality 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 continual improvement projects , supporting adoption of innovative manufacturing technologies and product improvement initiatives.
• Owns the Training Curriculum for its Job Description and provides the necessary training and support to new associates joining this position.
• BSc. in Chemistry, Pharmacy, Mechanical Engineering, Chemical Engineering or Pharmaceutical Technology.
• Fluent in English and in local language.
• Seven 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 leading and executing process and cleaning 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.
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