Senior Analytical Quality Control Specialist

2 days ago


Singapore WUXI XDC SINGAPORE PRIVATE LIMITED Full time
Job Title: Senior Analytical Quality Control Specialist

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:
  1. 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.
  2. Develop and validate microbiological testing methods in line with regulatory guidelines.
  3. Analyze and interpret microbiological results, maintaining accurate documentation.
  4. 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.
Estimated Salary:$120,000 - $180,000 per annum

We offer a competitive salary, benefits package, and opportunities for growth and development in a dynamic and supportive environment.



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