Deskripsi Pekerjaan
Join GSK, a global leader in pharmaceuticals, to play a pivotal role in our Tuas Vaccines manufacturing site. We are seeking a highly skilled Senior Quality Control (QC) Specialist to provide critical technical support for Quality Control (QC) activities related to the introduction of new projects. This 2-year contract opportunity is perfect for a dedicated professional looking to contribute to the development of life-saving vaccines in a state-of-the-art facility.
As a Senior QC Specialist, you will ensure that all QC processes meet stringent global quality standards and regulatory requirements. You will work closely with cross-functional project teams to support the successful launch and ongoing operation of vaccine manufacturing lines. This role offers a unique chance to enhance your expertise in biopharmaceutical quality assurance within a dynamic and collaborative environment.
Tanggung Jawab
- Execute and manage complex QC testing protocols for vaccines and biologics in accordance with Good Manufacturing Practice (GMP).
- Monitor and ensure the quality of raw materials, intermediates, and finished products throughout the production lifecycle.
- Analyze laboratory data, prepare accurate technical reports, and support root cause investigations for quality deviations.
- Participate in the validation of new analytical methods, equipment, and software systems.
- Collaborate with the project team to define quality specifications and ensure compliance during project transitions.
- Maintain comprehensive documentation and records in compliance with regulatory audits.
- Conduct internal training and provide guidance to junior laboratory staff on QC procedures.
Kualifikasi
- Bachelor’s degree in Chemistry, Biology, Biochemistry, or a related Life Sciences discipline.
- Minimum of 3 to 5 years of progressive experience in Quality Control within the pharmaceutical or biotechnology industry.
- Strong working knowledge of GMP regulations, GLP, and relevant local regulatory frameworks (e.g., HSA).
- Experience with laboratory instrumentation (HPLC, GC, etc.) and data analysis software.
- Proven ability to work in a fast-paced, contract-based project environment.
- Excellent problem-solving skills, attention to detail, and strong interpersonal communication abilities.
- Ability to work flexible hours as required by project timelines.