On‑Site QA Senior Specialist — GMP Biopharma (Shift)

Lonza; Singapore; On-site; SGD 70,000 - 120,000; Full time

Benefits offered by this job

Medical insurance

Family coverage option

Company transport from MRT to Tuas

Professional growth opportunities

Job summary

Lonza Group in Singapore is seeking a QA Specialist/Senior Specialist to support daily QA activities for a multi-product cGxP contract manufacturing facility. This site‑based role requires active collaboration on manufacturing floor, documentation review, and real-time quality guidance to uphold GMP standards.

You will review deviations, implement CAPA, and coordinate product release activities while ensuring compliance with SOPs and regulatory expectations.

Qualifications

• 1–3 years of QA experience in biopharma or GMP-regulated environment.
• Hands-on work with manufacturing activities and cross-functional teams.
• Strong understanding of GMP, quality systems and regulatory expectations.

Responsibilities

• Coordinate lot disposition and product release activities, including shipping documentation.
• Review and approve SOPs, protocols, reports, batch records, and other quality-related documents.
• Provide Quality oversight of product status and the quality tag-out system.
• Review deviation investigations, applying Root Cause Analysis to support timely closure.
• Oversee CAPA implementation and ensure timely and effective closure.
• Provide real-time Quality guidance on manufacturing floor activities in accordance with GMP, SOPs, and policies.
• Support manufacturing changeovers and day-to-day QA activities within a GMP biopharmaceutical facility.
• Identify cGMP/GDP non-compliance and provide appropriate corrective guidance.
• Analyze data, resolve quality issues, and recommend process improvements.
• Participate in manufacturing walkdowns, Regulatory and Customer Audits, and related follow-up activities.
• Lead and coordinate Quality projects and continuous improvement initiatives.
• Provide compliance guidance and Quality support to cross-functional teams.

Skills

QA operations

GMP knowledge

Cross-functional collaboration

Root Cause Analysis

Education

Bachelor's degree in a relevant discipline

Tools

Documentation systems

Job description

Lonza Group in Singapore is seeking a QA Specialist/Senior Specialist to support daily QA activities for a multi-product cGxP contract manufacturing facility. This site‑based role requires active collaboration on manufacturing floor, documentation review, and real-time quality guidance to uphold GMP standards.

You will review deviations, implement CAPA, and coordinate product release activities while ensuring compliance with SOPs and regulatory expectations.