Deskripsi Pekerjaan
Are you looking for a challenging and impactful role within the pharmaceutical sector? Steward Cross Pte Ltd is seeking a dedicated PV & QA Admin/Associate to join our team in Toa Payoh. In this vital position, you will play a key role in the pharmaceutical product lifecycle, ensuring strict adherence to drug safety protocols and regulatory compliance standards.
This hands-on role offers the opportunity to drive Quality Assurance (QA) initiatives and support Pharmacovigilance (PV) activities. You will be responsible for managing critical documentation, ensuring data integrity, and assisting in regulatory submissions. We are looking for a detail-oriented professional who is passionate about maintaining the highest standards of safety and compliance in healthcare.
If you possess a strong background in administrative support within a regulated environment and are eager to contribute to a dynamic team, we encourage you to apply.
Tanggung Jawab
- Assist in the processing and evaluation of adverse event reports (AERs) within the Pharmacovigilance (PV) system.
- Manage and maintain Quality Assurance (QA) documentation, including batch records, SOPs, and change control logs.
- Support regulatory affairs by preparing and filing necessary documents for local and international authorities.
- Conduct routine data entry and file management to ensure accuracy, traceability, and accessibility of records.
- Coordinate with cross-functional teams to address quality issues and implement effective corrective actions.
- Participate in internal audits and prepare comprehensive documentation for external inspections.
- Monitor and update regulatory guidelines to ensure ongoing compliance with GMP/GDP standards.
Kualifikasi
- Degree in Pharmacy, Life Sciences, or a related field is preferred.
- Familiarity with GMP (Good Manufacturing Practice) and GDP (Good Distribution Practice) guidelines.
- Strong attention to detail with the ability to maintain high standards of documentation accuracy.
- Proficient in Microsoft Office applications (Word, Excel, PowerPoint).
- Excellent written and verbal communication skills in English.
- Previous experience in PV or QA administration is a distinct advantage.
- Ability to work independently and manage multiple priorities in a fast-paced environment.