
Senior Specialist 1, Operations QA
4 days ago
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.
- 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).
- 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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