Deskripsi Pekerjaan
We are seeking a detail-oriented and proactive QA Executive to join our pharmaceutical manufacturing team in Changi. In this role, you will be responsible for ensuring compliance with Quality Management System (QMS) standards, including GMP (Good Manufacturing Practice) and ISO requirements. You will play a key role in supporting internal and external audits, developing and delivering training programs, managing CAPA (Corrective and Preventive Actions), and overseeing batch release processes to ensure product safety and efficacy.
Responsibilities include maintaining and updating quality documentation, conducting risk assessments, and implementing process improvements. You will collaborate closely with production, regulatory, and quality control teams to maintain the highest standards of product quality and safety, ensuring adherence to Singapore Health Sciences Authority (HSA) regulations and international standards.
The ideal candidate will have a strong understanding of pharmaceutical quality assurance principles, regulatory guidelines, and documentation requirements. Excellent communication skills, attention to detail, and the ability to work under pressure are essential.
This is an excellent opportunity for a professional looking to advance their career in the pharmaceutical industry while contributing to a dynamic and growing organization. We offer competitive compensation, ongoing training, and career development opportunities.
Tanggung Jawab
- Ensure compliance with QMS standards, GMP, and ISO regulations.
- Support internal and external audits, including preparation and follow-up actions.
- Develop and deliver training programs on quality standards and procedures.
- Manage CAPA processes, including investigation, implementation, and effectiveness checks.
- Oversee batch release processes to ensure product quality and safety.
- Maintain and update quality documentation and records.
- Conduct risk assessments and implement corrective actions.
- Collaborate with cross-functional teams to drive continuous improvement.
Kualifikasi
- Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or related field.
- Minimum 2-3 years of experience in QA within the pharmaceutical or healthcare industry.
- Strong knowledge of GMP, ISO, and relevant regulatory guidelines (e.g., HSA).
- Experience in managing audits and CAPA processes.
- Excellent attention to detail and organizational skills.
- Strong communication and interpersonal skills.
- Proficiency in Microsoft Office and quality management software.
- Ability to work independently and as part of a team.