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

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

Job summary

A leading pharmaceutical company in Singapore is seeking an experienced professional to lead equipment qualification for analytical equipment and support its lifecycle management. The ideal candidate holds a relevant degree and possesses 2-3 years of experience in the pharmaceutical industry, ideally with background in analytical equipment qualification and QC testing. Strong communication skills and knowledge of regulatory requirements are essential for this role. Apply through the company's recruitment website.

Qualifications

• Minimum 2-3 years of relevant working experience in the Pharmaceutical Industry.
• Experience in analytical equipment qualification including computer system validation.
• Knowledge of the operation of analytical equipment will be an advantage.
• Experience in QC testing will be an advantage.
• Knowledge of compendia and regulatory requirements.

Responsibilities

• Leads analytical equipment qualification for new equipment / technology introduction.
• Ensures timely implementation of projects with compliance to regulations.
• Collaborates closely with stakeholders on new equipment / technology introduction.
• Writes change controls, events, deviations, CAPAs and GMP documents.
• Ensures spending is within project target budget.

Skills

Analytical equipment qualification

Good communication skills

Ability to work independently

Knowledge of cGLP & cGMP

Education

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

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.