XDC QC Senior scientist for QC operation

WUXI XDC SINGAPORE PRIVATE LIMITED; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading biotechnology company in Singapore is seeking a qualified individual for managing test samples, ensuring compliance with cGMP, and maintaining QC equipment and instruments. Candidates should have a strong understanding of the drug development process and regulatory requirements. This is a full-time on-site position.

Qualifications

• Good understanding of overall drug development process.
• Thorough management of cGMP compliance principles.
• Knowledge of FDA, EMA, NMPA guidelines, and pharmacopoeias.

Responsibilities

• Manage test samples including in-process, release, and stability samples.
• Handle regulatory retain sample management.
• Ensure compliance of QC team activities with cGMP and EHS requirements.

Skills

QC instrument and equipment management

Understanding of drug development process

cGMP compliance knowledge

Knowledge of FDA guidelines

Job description

Responsibilities

• Management of test samples: In-process and release samples, environmental testing samples and drug substance and excipient samples
• Stability sample management.
• Regulatory retain sample management.
• Reference sample management
• Responsible for QC instrument and equipment management, like C type instruments including HPLC, GC, IC and LC-MS and B type instruments pH, balance and colorimeter.
• Responsible for electronic system application, including but not limit to LIMS, EMPOWER and LES.
• Ensure all the activities in QC team performed with compliance of cGMP, data integrity and EHS requirement.

Other special requirements

• A good understanding of the overall view of drug development process.
• A thorough understanding of the principles and management of cGMP compliance, and strong quality minds.
• Comprehensive knowledge in FDA, EMA, NMPA, ICH, WHO technical guideline and USP, Eur.P, ChP pharmacopoeias.
• Comprehensive knowledge in IND/IMPD, NDA and ANDA filing
• Full time on-site work requirements