Lead, MS&T Validation
Lead, MS&T Validation
• Support Product Steward, Validation Expert and Commercial Support Leads, 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: • Develop and oversee site validation planning by defining, drafting and assisting to maintain master plans for process, cleaning, shipping and subsequent ongoing verification (as applicable). • Own 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 leader in quality risk management activities. •Author and review process, process, shipping or cleaning validation protocols & reports, and subsequent ongoing / continuous verification protocols & reports. •Oversee and take accountability for the execution of validation activities at the shop floor. •Support network requirements for KPI reporting. •Reviews Master Batch Records and associated change controls. Confirm revalidation need based on technical changes •Maintain all activities and projects under area 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 GMP; manage deviations associated with validation strategies and make recommendations for deviation resolution as well as prevention of reoccurrence.
Launch & Transfer: •Work in close collaboration with sending unit 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. •Guide the network for best practices in areas of expertise
Minimum requirements• BSc. in Chemistry, Pharmacy, Chemical Engineering or Pharmaceutical Technology.
•12+ years experience in manufacturing / manufacturing science and technology / technical validation or quality validation.
•Thorough understanding of manufacturing processes and related process equipment.
•Strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities.
•10+ year experience in executing process validation, with increasing scope related to leading/managing validation projects and teams.
•Expert in reviewing and writing technical reports.
•Proven project management experience in a cross-functional environment (e.g. multi-site, technical development, other functions).
•Strong understanding of pharmaceutical analytical methods/tests