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Manufacturing Support Supervisor - Change Control and Documentation Management

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At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Discover more at takedajobs.com.

 

Manufacturing Support Supervisor - Change Control and Documentation Management

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Discover more at takedajobs.com.

 


This is an exciting career opportunity for a dynamic, autonomous, continuous improvement minded and change agile manufacturing professional to embrace a team-based culture and more specifically within the manufacturing teams within a world-class Biotech manufacturing environment.

 

Your mission

Within the Manufacturing support department, reporting to the Head of Manufacturing support group, the purpose of this role is to be supervisor of the team in charge of change controls and documentation management for the production department. The main aspects of this position are focused on people management and development, respect of applicable procedures and requirements, promotion and deployment of continuous improvement culture, definition of priorities within the group in accordance with the production planning and needs.

 

Essential Duties & Responsibilities

  • Provide feedback to the team and focus on team development
  • Promote, participate and launch manufacturing process improvement and/or enhancement projects
  • Lead change management and documentation activities within the framework of production and monitor appropriate quality systems
  • Deploy and drive metrics related to changes, documentation and other activities of the team and provide regularly analysis and actions to the Manufacturing leadership team and to the floor
  • Ensure change control system is respected and changes are implemented as appropriate (e.g. adequate evaluation of proposed changes, user readiness assessed, risk mitigation anticipated, communication plans  defined, …)
  • Drive initiatives to ensure standardization and consistency of the documentation and of the change control process for all the production units
  • Ensure production documentation is up-to-date
  • Provide work direction, assignments for validation protocols, for review of computerized & automated systems documentation, for risk assessments
  • Provide day-to-day work direction, expertise and coaching to the team to meet the production priorities
  • Support/coach Subject Matter Experts (SMEs) and production team during internal and external audits for selected topics
  • Incorporate and ensure respect of cGMP concepts (Good Manufacturing Practices) and EHS requirements

 

Required Skills

  • Confirmed experience and interest in manufacturing operations, associated processes and documentation
  • Ability to think, take initiatives and act cross-functionally, interacting with EHS, QA, QC, engineering, project departments, etc...
  • Ability to work in a fast, dynamic and diverse business environment with a high emphasis on achieving results
  • Ability to supervise different types of activities, with appropriate prioritization to ensure deadlines are met in timely, costly and quality manner
  • Strong focus on customer service, standardization and continuous improvement

 

Personal qualities

  • Good leadership and interpersonal skills, self-motivated, structured, capable of analyzing complex situations through innovative thought and experience, strong decision-making skills
  • Ability to work well and develop relationships with all levels of internal management, with the team and with the partners within and outside production department
  • Demonstrate excellent communication skills, can adapt style to the audience
  • Great team player prepared to work in and embrace a team-based culture and more specifically within the manufacturing teams directly on the production floor
  • Excellent oral and written skills in English and French, fluency is an asset

 

Education & Experience

  • Bachelor/Master’s degree and minimum 5-8 years of experience within a biotech/pharmaceutical manufacturing environment (Process Operations, Engineering or Quality)
  • Demonstrated experience in people management
  • Demonstrated experience in “change control” management, including in Regulatory Affairs activities related to significant changes
  • Expertise in Quality/Compliance within an FDA regulated/GMP manufacturing field
  • Project management training or experience, an asset (from URS to implementation)

 

Working Environment

  • While this is a day-time job, must be able to work on occasions in controlled environments (ISO 5, ISO 7 and ISO 8 environments; grade A, B and C) requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.

Adresse

Pierre-à-Bôt 111 2000 Neuchâtel

Website http://www.shire.com

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