Deskripsi Pekerjaan
GSK is a global leader in pharmaceuticals, vaccines, and biotechnology. We are currently seeking a dedicated and detail-oriented QA Executive / Senior QA Executive to join our team on a 2-year contract basis in the West Region. This is a pivotal role within our Operations team, specifically focused on supporting our New Product Introduction (NPI) and product transfer initiatives.
In this position, you will play a key role in ensuring that our manufacturing processes meet the highest standards of quality, safety, and compliance. You will be responsible for leading and supporting validation activities for major product transfers, ensuring that all systems, processes, and equipment are validated according to regulatory requirements. Your expertise will be crucial in bridging the gap between technical execution and quality assurance, ensuring smooth transitions for new products entering the market.
As part of a dynamic cross-functional team, you will collaborate closely with engineering, operations, and regulatory affairs to drive continuous improvement and maintain GSK's reputation for excellence. If you are a proactive professional looking to advance your career in a global pharmaceutical environment, we encourage you to apply.
Tanggung Jawab
- Lead and support the execution of validation activities for New Product Introduction (NPI) and product transfer projects, ensuring all protocols are followed.
- Ensure strict compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other regulatory standards during all phases of product development.
- Manage and review technical documentation, including validation protocols, reports, and change control requests.
- Conduct internal audits and inspections to identify gaps and implement corrective actions.
- Collaborate with cross-functional teams to resolve technical issues and ensure the timely completion of validation deliverables.
- Maintain accurate records and ensure data integrity in accordance with company and regulatory requirements.
Kualifikasi
- A relevant Degree in Chemistry, Pharmacy, Life Sciences, or a related engineering discipline.
- Minimum 3-5 years of experience in Quality Assurance or Quality Control within the pharmaceutical or life sciences industry.
- Strong working knowledge of GMP, ICH guidelines, and regulatory requirements (e.g., MFDS, FDA, EMA).
- Experience with validation activities, including Protocol and Report writing, is highly desirable.
- Excellent analytical skills with the ability to interpret complex technical data and regulatory texts.
- Strong communication skills, both written and verbal, to interact effectively with diverse stakeholders.
- Ability to work independently as well as part of a team in a fast-paced manufacturing environment.