Senior Expert

2 days ago

Tuas South Avenue, Singapore Novartis Full time $80,000 - $120,000 per year

Job Description Summary

Primary responsibilities for this position include performing tasks associated with release testing and reviewing laboratory data, coordinating the team/lab under its responsibility. Communicating with internal & external partners for the Quality Control organization. Supports site as technical expert in related field

Job Description

Key Responsibilities:

  • Act as SME in the area of equipment calibration and qualification in the QC laboratory ensuring compliance with local and global procedures while minimising the impact on the business
  • Coach trainers to ensure effective training of QA/QC analysts in area of laboratory equipment and qualification by developing and advising standardized content, materials and assessment tools.
  • Act as SPOC for major QC equipment projects and liaise closely with end users and other departments in relation to cross-functional projects
  • Management of QC investment budget/QC asset management and utilisation/QC CapEx projects.
  • Troubleshoot and resolve challenging issues relating to modifications of current quality compliance processes and systems within and across various functions to ensure all health, safety or training procedures meet requirements.
  • Lead cross functional project teams to drive team results including Lab Excellence projects
  • Initiate and supervise the Strive to constantly continuous improvement of systems and practices on site with respect to achieve compliance, reducing waste and improving efficiencies
  • Stand in for other team members in the QC Support Services team in their absence.

Essential Requirement:

  • BS: 6+ years related experience with 3+ years in management
  • Related experience should be in GMP-regulated industries in Quality Control.
  • Must have a working knowledge of health authority and regulatory requirements as well as industry quality management tools, standards, and quality systems.
  • Must have an understanding of pharmaceutical industry trends and practices.
  • Broad cGMP experience is required with knowledge and understanding of manufacturing, quality control, and validation requirements and activities.

Desirable Requirement:

  • English fluent in speaking and writing. Mandarin Chinese a plus

Skills Desired

Continued Learning, Dealing With Ambiguity, Decision Making Skills, Gxp, Industry Standards, Laboratory Equipment, Laboratory Excellence, Managing Resources, Organizational Savvy, Quality Control (Qc) Testing, Quality Control Sampling, Self-Awareness, Smart Risk Taking, Technological Expertise, Total Quality Management

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