Senior Quality Assurance Specialist

2 weeks ago

Tuas West Region, Singapore ScaleUp Bio Full time $80,000 - $120,000 per year

Your Responsibilities:

  • Act as the primary point of contact for QA-related topics for both customers and internal stakeholders.
  • Provide routine updates to customers on QA-relevant topics
  • Coordinate and deliver product-specific documents in a timely manner
  • Coordinate and present quality reviews to internal stakeholders and customers as required.
  • Lead investigations for customer complaints and ensure records are closed in accordance with customer requirements and internal SOPs.
  • Provide QA oversight in customer project-related activities, including review and approval of batch records and/or CAPA outside of routine operations, ensuring accuracy, timely delivery, and compliance with quality requirements.
  • Provide QA Operations oversight to site improvement projects
  • Attend and contribute constructively in internal and external customer project meetings.
  • Participate in and/or lead resolution of complex process or project issues.
  • Coach and indirect management of junior members of the QA team.
  • Formulate and articulate solutions to issues/problems for internal/external teams and management.
  • Represent QA Operations in cross-functional decision-making meetings (internal and external).
  • Maintain Site Master Validation plan, set objectives and ensure process validations performed to meet regulatory requirements.
  • Lead and Conduct internal audits, drive actions to implement CAPA.
  • Implement and maintain change control process for the site.
  • Any other duties as assigned by your Supervisor/Manager.

Your Profile:

  • Degree/Diploma in Life Sciences, Biotechnology, Chemistry, or related discipline.
  • Relevant QA experience in the pharmaceutical, biotech, or related life sciences industry.
  • Strong understanding of cGMP requirements and QA processes.
  • Proven ability to manage customer interactions and deliver quality documentation in a timely manner.
  • Knowledge or experience in food safety requirements
  • Prior work experience in implementation and maintenance of ISO22000, FSSC22000, BRC or relevant certification is advantageous
  • Proficient in written and spoken English
  • Computer-literate with knowledge of MS Office applications
  • Knowledge of Microsoft Dynamics is a plus
  • Possess good self-discipline
  • A good team player with strong initiative and an analytical mind

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