Senior Specialist 1, Operations QA

3 days ago

Central Region, Singapore Randstad – Lonza Full time $80,000 - $120,000 per year

The QA Specialist will support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, GxP contract manufacturing facility.

What you will get
  • An agile career and dynamic working culture.
  • An inclusive and ethical workplace.
  • Compensation programs that recognize high performance.
  • Daily company bus from the MRT location near your home to and from the Tuas site.
  • Fully paid medical insurance, and option to enroll family members at partially subsidized premiums.
What you will do:
  • 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 (e.g., weekly deviation updates).
  • Attend and contribute constructively in internal and external customer project meetings.
  • Coordinate and deliver product-specific documents (e.g., Quality Agreements, Product Quality Reviews, or similar reports) in a timely manner to meet customer satisfaction.
  • 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 product-specific documents or Trackwise records outside of routine operations, ensuring accuracy, timely delivery, and compliance with quality requirements. Examples include but are not limited to: PQR, sampling plans, control plans, process descriptions, BLA content, new product introductions, customer suspension/decommissioning, product recalls, and OOS records.
  • Provide QA Operations oversight to site-wide improvement projects.
  • Participate in and/or lead resolution of complex process or project issues.
  • Guide and coach 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).
What we are looking for
  • 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.
  • Excellent problem-solving skills with the ability to resolve complex issues.
  • Strong communication and interpersonal skills to work effectively with cross-functional teams.
  • Experience in mentoring or coaching team members is an advantage

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