QC Operations Specialist

Company

WuXi XDC

Location

singapore, Singapore

Type

Full-time

            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 
Perform annual fixed asset review 
Provide audit support such as audit preparation and as SME for related areas 
Project Management 
Archival of QC Documentation 
Ensure all the activities in QC team performed with compliance of cGMP, data integrity and EHS requirement. 
 Requirements  Bachelor's degree or above in pharmacy, chemistry, biochemistry, analytical chemistry or other related discipline 
6 to 12 years working experience in biotech or biopharma 
Deep understanding of FDA, EMA, ICH related regulations 
Good command of spoken and written English 
 Other Special Requirements  
        
        
    

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