Senior Quality Manager

Permanent Position
17 Oct 2020
Expires on 15 Nov 2020

Company Description

Pharma MNC

Posted by

Lina Feng (Reg No: R1987768)

Tel

+65 9652 3371

Email

Job Description

  • Identify and ensure implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design of and ensure equipment, tools, fixtures, etc are up to standards
  • Design and implementation of Quality systems (such as QTS, PDocs, SAP workflow)
  • Be the quality lead to work with cross-functional teams and Business technology team on seamless integration of relevant IT systems with other systems
  • Provide Quality input and support to design phases for significant projects including those for QC laboratories
  • Review and pprove changes related to site projects to ensure that they meet the design and compliance requirements
  • Lead and manage a team of validation specialists to ensure that validation projects/program are delivered in a timely manner
  • End to end work processes for QC lab
  • Interphase with lab operations to ensure timely procurement and qualification of lab equipment and smooth method transfers activities
  • Responsible for Regulatory queries pertaining to site projects and work with Regulatory contacts (local/network) to establish regulatory strategies and solutions for the plant
  • Manage and control operations section as per the budget plan

Requirements

  • Degree in Chemistry, Microbiology, Engineering or other Science related discipline; MBA or graduate degree an advantage
  • 10+ years of experience in pharmaceutical manufacturing or quality, compliance background experience is an advantage
  • SME in Manufacturing, Quality Systems or Regulatory or Compliance processes
  • Demonstrated ability to manage multiple projects
  • Ability to collaborate with cross-functional teams to understand their expectations while supporting the plant quality systems and processes
  • Firm understanding of the concepts incorporated in Quality Assurance in a GMP environment
  • Demonstrated personal leadership, accountability, and organizational skills with proven ability to operate independently with minimal supervision

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