QC Specialist (CSV / Equipment Qualification) 1 year Contract

GMP TECHNOLOGIES (S) PTE LTD; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading technology firm in Singapore is seeking a qualified professional to lead equipment qualification for analytical tools. The role involves ensuring compliance with GMP guidelines, collaborating with both local and global stakeholders, and writing essential documentation such as SOPs and validation protocols. Ideal candidates should hold a degree in relevant fields, have hands-on experience in a cGMP environment, and possess strong communication skills. This position offers an opportunity to work in a highly regulated manufacturing environment.

Qualifications

• Hands-on experience in analytical equipment qualification in a cGMP environment.
• Strong understanding of GMP, GxP, and data integrity principles (ALCOA+).
• Experience in writing and reviewing documentation such as IQ/OQ/PQ.

Responsibilities

• Leads analytical equipment qualification for new technology introduction.
• Collaborates with local and global stakeholders.
• Writes change controls and GMP documents.

Skills

Analytical equipment qualification

Computer System Validation (CSV)

GMP compliance

Writing GMP documentation

Good communication skills

Education

Degree in Pharmaceutical Sciences, Chemistry, Life Sciences, Biotechnology, or Engineering

Job description

Job Description

Leads equipment qualification for new/existing analytical equipment and supports the transition of the knowledge to local QC unit for lifecycle management.

Jobscope

• Leads analytical equipment qualification for new equipment / technology introduction.
• Ensures timely implementation of the projects with full compliance to corporate, regulatory and external agency regulations if applicable.
• Collaborates closely with local and global stakeholders on new equipment / technology introduction and qualification.
• Writes change controls, events/ deviations, CAPAs and GMP documents (e.g. SOP, protocols, reports).
• Ensures spendings are within project target budget.

Requirements

• Degree in Pharmaceutical Sciences, Chemistry, Life Sciences, Biotechnology, Engineering, or related discipline.
• Hands‑on experience in analytical equipment qualification within a cGMP environment.
• Proven experience in CSV for analytical instruments and laboratory computerized systems.
• Strong understanding of GMP, GxP, data integrity (ALCOA+), and regulatory expectations.
• Experience in writing and reviewing GMP documentation such as IQ/OQ/PQ, validation protocols, reports, and SOPs.
• Familiarity with change management, deviation investigation, and CAPA processes.
• Good communication skills and ability to work independently in a highly regulated manufacturing environment.
• Experience working in a cGMP laboratory environment.
• Ability to ensure compliance with regulatory guidelines (FDA, EMA, PIC/S) and data integrity principles (ALCOA+).

To apply, please visit www.gmprecruit.com.

To learn more about this opportunity, please contact Dianna at [e-mail].