Manufacturing Support Supervisor - Change Control and Documentation Management

Takeda — Neuchâtel
10.10.2019 | Employee | 100%

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.

Manufacturing Support Supervisor - Change Control and Documentation Management

 

R0036545

 

Here, everyone matters, and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.

 

An exciting and challenging opportunity has become available at Takeda’s Neuchatel Manufacturing plant (approx. 650 employees) for an experienced

 

Manufacturing Support Supervisor -  Change Control and Documentation Management

 

to join our Manufacturing support team.

 

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.

 

 

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Takeda’s Talent Acquisition team. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

 

 

 

 

Notice to Employment / Recruitment Agents:

 

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

10.10.2019
Employee, 100%

Contact

Takeda
Pierre-à-Bôt 111
2000 Neuchâtel
No recruitment agencies please
Takeda
Pierre-à-Bôt 111
Neuchâtel

Industry

Biotechnology / Chemistry / Pharmaceutical

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Training Company
Training Company
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