QC Specialist Consultant (CSV / Equipment Qualification) (1 year contract) | Pharma | Tuas

GMP Technologies; Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

GMP Technologies is seeking a QC Specialist Consultant to lead equipment qualification (CSV) for new and existing analytical equipment at the Tuas site. The role supports lifecycle management by transferring knowledge to the local QC unit and ensuring regulatory compliance.

The ideal candidate has a degree in a relevant science/engineering field and 5–8 years of pharma experience, with strong communication skills and independence in a highly regulated manufacturing environment.

Qualifications

• Degree in Pharmaceutical Sciences, Chemistry, Life Sciences, Biotechnology, Engineering, or related discipline.
• Min. 5-8 years of relevant working experience in similar function in the Pharmaceutical Industry
• Experience in analytical equipment qualification (including computer system validation for analytical equipment)
• Knowledge of the operation of analytical equipment will be an advantage
• Experience in QC testing will be an advantage
• Knowledge of cGLP & cGMP
• Knowledge of compendia and regulatory requirements
• Good communication skills and ability to work independently in a highly regulated manufacturing environment.

Responsibilities

• 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.

Skills

Regulatory compliance

Analytical thinking

Communication skills

Education

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

Job description

QC Specialist Consultant (CSV / Equipment Qualification) (1 year contract) | Pharma | Tuas

Job Openings QC Specialist Consultant (CSV / Equipment Qualification) (1 year contract) | Pharma | Tuas

About the job QC Specialist Consultant (CSV / Equipment Qualification) (1 year contract) | Pharma | Tuas

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.
• Min. 5-8 years of relevant working experience in similar functionin the Pharmaceutical Industry
• Experience in analytical equipment qualification (including computer system validation for analytical equipment
• Knowledge of the operation of analytical equipment will be an advantage
• Experience in QC testing will be an advantage
• Knowledge of cGLP & cGMP
• Knowledge of compendia and regulatory requirements
• Good communication skills and ability to work independently in a highly regulated manufacturing environment.

We regret that only shortlisted candidates will be notified.