Plant Head

16 hours ago

Montreal Quebec GF, CA Lotus Pharmaceutical Co., Ltd Full time

KEY RESPONSIBILITIES

  • Plan, organize and manage the site, ensure timely production, product quality, plant safety and regulatory compliance. Establish, maintain and improve site facility, equipment and utility capability. Setup and improve department working flow, continuously improve productivity and operational efficiency, reduce operational cost. Assure site daily operation to meet or exceed the company strategic goals.
  • Prepare and implement company production plan, coordinate resources, improve productivity and operational efficiency, finish order timely, ensure product quality and process safety.
  • Responsible for department management and team building including managing plant daily operation, meeting client expectation, and ensuring GMP/EHS/FDA compliance.
  • Working closely with R&D teams, QA, QC, and other teams to ensure seamless tech transfer, success scale up and commercial production. Continue improving plant technical capability and engineering capacity. Develop and expand company manufacture capability and capacity to meet with the fast growth of business.
  • Manage plant EHS, meet regulatory requirement and customer expectation, ensure safe plant operation.
  • Establish plant policies and management procedures to enable business need. Manage day-to-day manufacturing activities, priorities, resources, cost control and trouble shooting
  • Establish and improve department working flow to optimize continuously equipment utilization and availability.
  • Manage budget, spending and budgeting variance.
  • Take necessary actions to ensure success of client audits and regulatory inspections and take measures for continues improvements. Develop and maintain good relations with local government.
  • Setup and improve department working flow, and to continuously optimize productivity and operational efficiency, reduce operational cost.
  • Support new RD products and manage transitions to new scales of commercial operations.
  • Build a highly efficient and motivated team. Motivate and develop team, build a strong leadership team, and empower team leaders. Establish systems to encourage innovation, collaboration and customer orientation.


PREREQUISITIES

  • Work onsite at Taiwan.
  • Good Pharma manufacturing experience with a strong customer focus.
  • Ability to work in a highly dynamic and complex manufacturing environment with up to 500 product SKUs.
  • Demonstrated capability in establishing new robust processes and improving legacy systems.
  • Technical competency in reviewing, approving and managing multiple high value CAPEX projects simultaneously.
  • Experience in handling external regulators including US-FDA, EMA and ANVISA
  • Exhibits professionalism in his/her work.
  • High level of initiative and able to work independently.
  • Advantage if candidate has lean-six sigma qualification.
  • Minimum 10 years of manufacturing experience in either Pharm or Biosciences industry.

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