QA Specialist

PERSOL; Singapore; On-site; SGD 70,000 - 90,000; Full time

Job summary

A recruitment agency seeks a qualified professional to support the Quality Management System in Singapore, ensuring compliance with local regulations. The ideal candidate will have a Bachelor's degree and at least four years of experience in a GMP or GDP environment. Proficiency in English and Microsoft Office is essential, alongside strong organizational and communication skills. The position involves collaboration with various teams to manage quality complaints and support regulatory audits.

Qualifications

• Experience in a GMP or GDP environment is required.
• Familiarity with Quality Systems processes.
• Demonstrates responsibility for completing work accurately.

Responsibilities

• Maintain the Quality Management System for compliance.
• Coordinate change control, deviation, and product complaints.
• Collaborate with Regulatory Affairs for audits and inspections.

Skills

Well-organized

Understanding of Good Manufacturing Practices (GMP)

Good Distribution Practices (GDP)

Good quality assurance principles

Strong communication skills in English

Proficiency in Microsoft Office applications

Familiarity with Veeva Vault or SAP ERP

Education

Bachelor's degree with 4+ years of experience

Master's degree with 2+ years of experience

Job description

Key Responsibilities

• Supports maintaining the Quality Management System in Australia and New Zealand to ensure that it meets local regulatory and industry standards and Gilead expectations.
• Supports the maintenance of relevant licenses.
• Supports and coordinates change control, deviation, CAPA, product complaints and any other QMS records.
• Assists in reviewing Annual Product Quality Reports (if applicable).
• Supports verification that shipping conditions match the product license/product label particulars and transporters are appropriately qualified.
• Supports Customer Services with GDP-related inquiries (e.g. delivery issues, transportation conditions, disputes, etc.).
• Supports communication with 3PL/4PL on supply-related issues.
• Supports the management of quality and distribution complaints.
• Supports product return and destruction activities.
• Ens customer validations and adequate records compliance with Gilead QA requirements are established and maintained for all local distributors/customers.
• Collaborates with RA to support inspections and audits as well as licenses maintenance.
• Collaborates with RA to implement activities for new product launch and product life cycle management.

Knowledge, Experience & Skills

• Well-organized individual with a proactive attitude and ability to work collaboratively, while managing tasks independently when required.
• Working experience and understanding of Good Manufacturing Practices (GMPs) and/or Good Distribution Practices (GDPs) within the pharmaceutical industry.
• Working knowledge of QA principles, concepts, and industry practices, with ability to apply them under guidance.
• Familiarity with Quality Systems processes (Deviation, CAPA, Change Control, Complaints, etc.) and ability to support their execution.
• Awareness of regional/local regulatory requirements and industry standards, with willingness to learn and apply.
• Strong verbal and written communication skills in English, and ability to work effectively in a team environment.
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, Teams).
• Familiarity with technology platforms such as Veeva Vault, SAP ERP, or willingness to learn.

Typical Educational Experience & Competencies

• Bachelors’ degree and 4+ years of relevant experience in a GMP or GDP environment-related field.
• Masters’ degree and 2+ years of relevant experience in a GMP or GDP environment related field.
• Ability to work collaboratively within a team and take initiative on assigned tasks under guidance.
• Demonstrates responsibility for completing own work accurately and on time, ensuring quality and compliance with established procedures.