descriptionHeader
Closing Date: 17th July 2017
CompanyLogo


Roche Singapore Technical Operations Pte Ltd
Head of MSAT

Purpose

  • Maintain the site’s Right to Operate and enable excellence in manufacturing by providing technical support to the production organization that results in safe, high quality, and continuously improving production.
  • Continuously monitor, analyze, optimize, and ensure validation of ongoing operations (production equipment, automation, and production and cleaning processes).
  • Anticipate, respond to and permanently resolve issues that arise during production
  • Partner with external and internal functions to transfer, implement, validate, file, and license new products/processes and maintain existing products/processes.
 
Key Responsibilities
 
Leadership & People Management:


  • Create an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation and inspire teams to achieve goals in the immediate and longer term.  Be an active and visible change agent, promoting flexible and open mindsets to new opportunities.
  • Establish strategic goals and objectives and maintain full strategic responsibility for the MSAT organization.
  • As a site leadership team member, drive collaboration within site and across network activities, cross-functional planning, and decision making.
  • Accountable for overall budget and financial performance of the MSAT organization.
  • Proactively promote positive Safety Culture and cGMP operating principles.
  • Embody PT lean leadership principles and methods while fostering a continuous improvement mindset
 
Technical:
  • Ensure Right to Operate through compliance with cGMP and regulatory requirements applicable to the department
  • Direct areas of responsibility:
  • Validation: Own, execute and improve the validation program for equipment, processes, and cleaning, and ensure compliance with PQS and HA requirements.  Represent Validation program during HA inspections.
  • Automation: Own, integrate, maintain and improve all production automation platforms at the site, and ensure compliance with PQS and HA requirements.
  • Tech Transfer: Partner with global and site functions to specify, transfer, file and license new products/processes in the plant.
  • Process Engineering: Establish oversight to ensure production is performed in conformance with license requirements, cGMPs, and global Health Authority expectations, and represent state of compliance during Health Authority inspections.  Drive continually monitoring of process to implement continuous improvement process
  • Technical Services: Respond to and proactively identify issues, determine root cause, and solve forever: Develop, prioritize and drive continuous improvements and other readiness operational maintenance activities that reduce safety risks, operational costs, lead times, and scrap/discrepancy rates across all aspects of production. 
  • Manufacturing Support: Provide technical support to manufacturing organization that includes process and product monitoring, master data and documentation management, compliance to Roche quality systems, and other readiness operational support activities
  • For specific sites:  Pilot Plant Operations: Build and maintain pilot plant operations to support Make-Assess-Release activities, tech transfers, and continuous improvement of the production plant.  Launch and PTD partner.
  • Operate as one network: Partner with global MSAT teams and network peers at other manufacturing sites to share and adopt best practices across the network that drive continuous improvement in all technical aspects of production.
  • Serve as a core member of the relevant Technical Council, provide site contributions to network technology roadmaps, ensure funding and execution of assigned projects on the respective site level.

Who you are
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

Qualifications

Education
  • Bachelor’s Degree required (science or engineering); additional requirements may be specified by site and local needs.
  • Graduate or higher-level Degree is preferred

Experience (may vary depending on site size/scope)
  • 12 or more years’ work experience in the pharmaceutical or related industry
  • 8 or more years’ people management experience
  • 4 or more years’ relevant engineering or project management experience in the pharmaceutical industry and/or a cGMP environment
  • Extensive experience with start-up and validation of manufacturing equipment, utility and process systems, including requirements for documentation and testing

Knowledge/Skills/Competencies
  • Expert knowledge of clean room or classified area design/requirements
  • Deep process, equipment, automation, validation and technical knowledge
  • Possesses strong verbal and written communication skills and the ability to influence at all levels.
  • Builds trustful and effective relationships
  • Able to think strategically and translate strategies into actionable plans
  • Takes responsibility, drives results, and achieves expected outcomes
Appointment to this position will be on local Singapore salary and benefits package.





 
descriptionfooter
Disclaimer|Terms of Use