Clinical Quality & Compliance Lead

PRESTIGE BIOPHARMA PTE. LTD.; Singapore; Presencial; SGD 60.000 - 100.000; Jornada completa

Descripción de la vacante

Prestige Biopharma Pte. Ltd. is seeking a Quality Assurance professional to ensure clinical trial processes comply with GCP and global regulatory standards. You will manage QMS document control, SOP reviews, and various audits to ensure data integrity and compliance across trials.

The role requires a strong background in regulatory guidelines, analytical problem solving, and excellent communication skills to interpret guidelines and implement effective improvements.

Formación

• Bachelor's degree or equivalent in basic sciences.
• Experience in pharmaceutical industry with knowledge of EU, US and other regulatory standards (GxP).
• Experience in clinical/regulatory auditing is desirable.
• Effective oral and written communication skills.
• Strong analytical and problem-solving abilities.
• Good computer skills and adaptability to new technology.

Responsabilidades

• Ensure clinical trial processes and procedures comply with GCP, regulations, protocol, and QMS.
• Conduct quality risk assessments and mitigations.
• Manage document control of the quality management system.
• Review and update SOPs and related documents.
• Prepare and conduct internal audits and site/vendor audits; report findings.

Conocimientos

Communication skills

Analytical skills

Computer literacy

Multitasking

Educación

Bachelor's degree or equivalent in basic sciences

Descripción del empleo

Prestige Biopharma Pte. Ltd. is seeking a Quality Assurance professional to ensure clinical trial processes comply with GCP and global regulatory standards. You will manage QMS document control, SOP reviews, and various audits to ensure data integrity and compliance across trials.

The role requires a strong background in regulatory guidelines, analytical problem solving, and excellent communication skills to interpret guidelines and implement effective improvements.