MSAT - Quality Engineer

Role Summary

Join GSK as a Quality Engineer within the Manufacturing Science and Technology (MSAT) team and play a vital role in ensuring the highest standards of quality and compliance in our manufacturing processes. In this role, you will collaborate with cross-functional teams to optimize processes, solve technical challenges, and drive continuous improvement initiatives.

Responsibilities

• Collaborate with cross-functional teams to investigate and resolve quality problems by identifying root causes and implementing corrective and preventative actions.
• Maintain accurate and up-to-date documentation related to Product Lifecycle Management (PLM). Ensure process improvements are sustained through in-use and effective review.
• Support and coach team members in procedures for managing quality problems (DMAIC, CAPA, Complaints) and make aware of the importance of quality and the issues involved.
• Apply structured problem-solving methodologies (e.g., 5 Whys, Fishbone, Human Error Evaluation) to support accurate and thorough documentation of root causes.
• Translate complex technical findings into clear, concise, and structured documentation using approved templates such as the Investigation Root Cause Analysis (DMAIC) and CAPA Template.
• Ensure consistency and traceability across investigation sections, carrying forward key information (e.g., problem statements, impact assessments) throughout the lifecycle of the report.
• Identify opportunities to improve product quality, manufacturing processes
• Participate in audits and inspections by providing documentation support and ensuring readiness of investigation records.

Qualifications

• Bachelor’s degree in engineering, chemistry, microbiology, or a related field.
• 3+ years of experience in a regulated manufacturing environment.
• Experience with validation protocols and risk assessments.
• Experience with GxP documentation and regulatory compliance.

Preferred Qualifications

• Advanced degree in a relevant field.
• Strong knowledge of quality engineering principles and regulatory guidelines.
• Excellent problem-solving skills and attention to detail.
• Familiarity with lean manufacturing and continuous improvement methodologies.
• Previous experience supporting regulatory audits and inspections.
• Strong organizational skills and ability to manage multiple projects simultaneously.
• Passion for innovation and driving process improvements.
• Effective communication and collaboration skills to work across teams.
• Experience with automated systems and validation software.
• Knowledge of Human Factors and error-proofing strategies.
• Ability to work independently and manage multiple priorities under tight deadlines.
• Analytical and problem-solving skills
• Familiarity with relevant industry standards and regulations