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

GMP TECHNOLOGIES (S) PTE LTD; Singapore; On-site; SGD 40,000 - 60,000; Full time

Job summary

A pharmaceutical company in Singapore is seeking a professional to lead analytical equipment qualification for new technologies. The ideal candidate will have a degree in a relevant field with 2-3 years of experience in the pharmaceutical industry, specifically in equipment qualification. Responsibilities include collaborating with stakeholders and ensuring compliance with regulatory standards. Strong communication skills and the ability to work independently in a regulated environment are essential. Salary and benefits will be discussed during the interview.

Qualifications

• 2-3 years of relevant working experience in the Pharmaceutical Industry.
• Experience in analytical equipment qualification is required.
• Knowledge of cGLP & cGMP is necessary.

Responsibilities

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

Skills

Analytical equipment qualification

Communication skills

Ability to work independently

Education

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

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.
• Min. 2-3 years of relevant working experience 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 apply, please visit to www.gmprecruit.com

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

We regret that only shortlisted candidates will be notified.

GMP Technologies (S) Pte Ltd | EA Licence: 11C3793 | EA Personnel: Fiona Koh | Registration No: R1109239

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