Kerja Sepenuh Masa, QC Metrology di WuXi XDC Southwest (Singapore) - Maukerja

Job Overview:

• To support and oversee Metrology works in QC

Job Description:

1. instrument/equipment routine maintenance
2. instrument/equipment qualification/requalification/retirement
3. instrument/equipment data backup & archival
4. instrument/equipment account management
5. Documentation updates

• 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 color meter.
• Responsible for electronic system application, including but not limited to LIMS, EMPOWER and LES.
• Ensure all the activities in QC team performed with compliance of cGMP, data integrity and EHS requirement.

Job Requirements:

1. A good understanding of the overall view of drug development process.
2. A thorough understanding of the principles and management of cGMP compliance, and strong quality minds.
3. Comprehensive knowledge in FDA, EMA, NMPA, ICH, WHO technical guideline and USP, Eur.P, ChP pharmacopoeias.
4. Comprehensive knowledge in IND/IMPD, NDA and ANDA filing
5. English can be as working language.
6. Experience with client management and internal departmental communications
7. Strong critical thinking, scientific reasoning and problem-solving skills