Join a globally recognized organization in the life sciences sector, known for advancing healthcare solutions through collaboration, innovation, and a commitment to excellence. Here, talented individuals work together to develop ideas that help improve lives around the worldand we believe in giving our people the freedom to shape their own career paths.
They are looking for a Quality Assurance Specialist to support daily QA functions within a large-scale GMP biologics manufacturing environment. This role offers the chance to develop expertise in advanced biotechnology processes while contributing to the production of therapeutic proteins.
Why Join Us
- A fast-paced, development-focused workplace within an international biotech leader
- A culture built on integrity, inclusivity, and respect
- Competitive pay programs that reward strong performance
- Opportunities for professional growth through cross-functional exposure and project involvement
- Comprehensive medical benefits, with subsidized options for dependents
- Company-provided transportation to and from designated MRT stations
- Full access to a wide range of employee benefits
What You'll Be Responsible For
- Supporting routine QA operations in alignment with established procedures in a multi-product, regulated manufacturing facility
- Monitoring operational processes and identifying factors that may impact compliance or performance
- Reviewing and approving documentation such as SOPs, protocols, records, and technical reports
- Troubleshooting quality-related issues and determining appropriate corrective actions
- Leading small-scale projects and ensuring timely completion of deliverables
- Building strong partnerships with teams across manufacturing, quality, and external stakeholders
- Coordinating upcoming QA tasks with other departments to ensure alignment
- Developing into a subject-matter trainer for designated quality systems or processes
- Reviewing batch documentation, initiating deviations, and compiling product genealogy
- Escalating process events in accordance with internal requirements
- Supporting production changeovers and document revisions
- Identifying and addressing gaps in GMP/GDP compliance
- Participating in audits, facility walkdowns, and continuous improvement initiatives
- Taking part in investigations, change control processes, and CAPA development
What You Bring
- Degree with 35 years of experience in a similar industry or QA role, or
- Diploma with 57 years of relevant experience
- Understanding of regulatory expectations such as FDA, EMEA, and ICH guidelines
- Working knowledge of GMP quality systems and their practical application
- Strong attention to detail, organized work habits, and commitment to safety and quality
- Ability to work independently while contributing effectively to team goals
Please note: This job posting is just a preview of the full scope of the position. A comprehensive job description is shared by a member of our team
