QC CSV Specialist (Analytical Equipment)

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

Job summary

A global consulting firm based in Singapore is looking for a professional to lead analytical equipment qualification for new technologies. The role involves ensuring compliance with regulations, leading project implementation, and collaborating with various stakeholders. Candidates should have a relevant degree or diploma, experience in analytical equipment validation, and strong project management skills. The company values diversity and promotes an inclusive environment with numerous benefits including continuous learning opportunities and a vibrant culture.

Benefits

Global diversity within the workforce

Continuous learning opportunities

Vibrant culture with networking and events

Qualifications

• Experience in analytical equipment qualification, including computer system validation.
• Knowledge of cGLP and cGMP regulations.
• Experience in QC testing.

Responsibilities

• Lead analytical equipment qualification for new equipment and technology.
• Ensure compliance with corporate and regulatory standards.
• Collaborate with stakeholders on equipment introduction and qualification.

Skills

Analytical equipment qualification

Project management

Strong communication skills

Fluent English

Education

University degree in a relevant science discipline

Diploma with relevant working experience

Tools

GMP documents

Analytical equipment

Job description

Job Overview

Lead analytical equipment qualification for new equipment and technology introduction. Ensure timely implementation of projects with full compliance to corporate, regulatory, and external agency regulations. Collaborate closely with local and global stakeholders on new equipment and technology introduction and qualification. Write change controls, events/deviations, CAPAs, and GMP documents (e.g., SOPs, protocols, reports).

Responsibilities

• Lead analytical equipment qualification for new equipment and technology introduction.
• Ensure timely implementation of projects with full compliance to corporate, regulatory, and external agency regulations.
• Collaborate closely with local and global stakeholders on new equipment and technology introduction and qualification.
• Write change controls, events/deviations, CAPAs, and GMP documents (e.g., SOPs, protocols, reports).

Qualifications

• Experience in analytical equipment qualification, including computer system validation for analytical equipment.
• Knowledge of the operation of analytical equipment.
• Experience in QC testing.
• Knowledge of cGLP and cGMP.
• Knowledge of compendia and regulatory requirements.
• University degree in a relevant science discipline with at least 2 years of relevant working experience, or diploma with at least 3 years of relevant working experience.
• Fluent English. Other languages are a plus.
• Strong project management and communication skills.

Benefits

• Global diversity: international team of over 110 nationalities.
• Trust and growth: 70% of leaders start at entry level.
• Continuous learning: internal Academy and 250+ training modules.
• Vibrant culture: afterworks, networking events.
• Meaningful impact: CSR initiatives such as WeCare Together program.

Equal Opportunity

Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.