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

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

Job summary

A leading pharmaceutical company in Singapore is looking for a QC Specialist Consultant on a 1-year contract. The role involves leading the qualification of analytical equipment, ensuring project compliance with regulatory standards, and collaborating with global stakeholders. Candidates should have a degree in a related field and 5-8 years of experience in the pharmaceutical industry. Strong communication skills and knowledge of cGMP are essential for success in this role.

Qualifications

• Minimum 5-8 years of experience in the Pharmaceutical Industry.
• Experience in computer system validation for analytical equipment.
• Knowledge of cGLP & cGMP.

Responsibilities

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

Skills

Analytical equipment qualification

Good communication skills

Ability to work independently

Education

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

Job description

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 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.

To find out more about this opportunity, please contact Fiona Koh; [e-mail]

We regret that only shortlisted candidates will be notified.

By applying for this role, you consent to GMP Recruitment Services (S) Pte Ltds PDPA and e2is PDPA.