Senior Analytical Quality Control Specialist
2 days ago
WUXI XDC SINGAPORE PRIVATE LIMITED is seeking a highly skilled and experienced Senior Analytical Quality Control Specialist to join our team.
Job Description:- We are looking for a professional with extensive experience in analytical testing and quality assurance activities, including raw material testing, in-process control, environmental monitoring, water testing, and finished product testing.
Key responsibilities include:
Responsibilities:- Conduct various analytical tests, including CE-SDS, cIEF, cell-based potency assays, ELISA-based qualification, Karl Fischer titration, Total Organic Carbon (TOC) testing, UV-Vis spectrophotometry, FTIR, manual and automated titration, bioburden, sterility, container closure integrity testing (CCIT), and endotoxin testing.
- Develop and validate microbiological testing methods in line with regulatory guidelines.
- Analyze and interpret microbiological results, maintaining accurate documentation.
- Assist in investigating out-of-specification results and implementing corrective actions.
To be successful in this role, you should have a strong understanding of the drug development process and excellent knowledge of cGMP compliance principles. You should also be proficient in English as a working language and have extensive experience with IND/IMPD, NDA, and ANDA submissions.
Requirements:- Bachelor's degree or higher in pharmacy, chemistry, biochemistry, analytical chemistry, or related fields, with a minimum of 2 years of experience in biotech or biopharma.
- Strong understanding of the drug development process.
- In-depth knowledge of cGMP compliance principles and a strong quality-focused mindset.
- Familiarity with FDA, EMA, NMPA, ICH, WHO technical guidelines, as well as USP, Eur.P, and ChP pharmacopeias.
- Extensive experience with IND/IMPD, NDA, and ANDA submissions.
- Proficiency in English as a working language.
We offer a competitive salary, benefits package, and opportunities for growth and development in a dynamic and supportive environment.
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