Senior Technical Support Specialist

Complete deviation investigations to insure deviations are thoroughly investigated using appropriate problem solving tools, corrective / preventative actions (CAPAs) are properly developed and implemented and consistent documentation is provided. Lead or support continuous improvement process resulting in improvements in site capacity, quality, yield, efficiency and cost. Lead or support aseptic improvement projects in conjunctions with subject matter experts (SME) to insure product quality and consistent plant operations. Lead problem solving or project teams related to deviations and continuous improvement.

Deviation Investigation: • Conduct thorough investigations for deviations that occur in the manufacturing and distribution process. Utilize proven problem solving tools and statistical analysis to drive the development of effective CAPAs to prevent recurrence thereby reducing Reject Rate, Recurring Deviation Rate, Cost of Quality and Rework. • Create consistent, detailed investigation documentation suitable for use with Health Authorities and Notified Bodies • Communicate status of investigations and escalation issues as appropriate. Continuous Improvement: • Support the site continuous improvement process (CIP) by completing CIP projects utilizing appropriate Lean Six Sigma (LSS) tools • Insure that financial impact results are confirmed by Finance and properly documented. • Drive LSS culture / mindset throughout the organization • Support the aseptic improvement process with the SME through effective team leadership of the Aseptic Core Team (ACT): o Completing the aseptic audit process and making recommendations based on these results o Defining and implementing aseptic improvement projects o Leading aseptic understanding throughout the organization o Improve with the Training department the aseptic practice training o Communicating the impact of the Aseptic Core Training: • Own the Training Curriculum for assigned Job Profile and provide training and support to new associates joining related functions. Audit Support: • Maintain assigned documentation and work area in inspection readiness level and provide necessary support in any internal or external audit.

  • Reject rate • Recurring Deviation rate • On-time release rate • Open deviations • Deviation closure time • CIP savings EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Minimum requirements BSc in Engineering, Pharmaceutical Technology, Chemistry or equivalent scientific degree.

Preferred: MSc, or equivalent experience.

Fluent in English and proficient in site local language.

  • Minimum 3-5 years experience in process support role of GMP Manufacturing and/or QA/QC.

Preferred: 7 years of manufacturing or quality experience.

  • Proven process understanding of pharma manufacturing, GMP, Quality and regulatory aspects.
  • Experience in the application of problem solving tools, continuous improvement tools and aseptic knowledge.
  • Ability to lead teams for problem solving or continuous improvement
  • Communicate effectively with all levels of the organization.

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