Senior Specialist – Analytical Quality Assurance (AQA)

PHARMAGEND GLOBAL MEDICAL SERVICES PTE. LTD.

Singapore, Singapore
Hplc and gc analytical techniques
Ich and fda regulatory compliance
Alcoa+ data integrity principles
This role ensures all analytical testing meets rigorous regulatory standards within a CDMO environment

Job Summary

  • This role ensures all analytical testing meets rigorous regulatory standards within a CDMO environment.
  • The specialist is responsible for reviewing analytical methods, validating data integrity, and managing deviations.
  • Candidates must possess strong technical knowledge of pharmacopeia guidelines and GMP requirements.

Matching Summary

Match Score: 75

This role ensures all analytical testing meets rigorous regulatory standards within a CDMO environment.

Skills & Requirements

Must-have

  • HPLC and GC analytical techniques
  • ICH and FDA regulatory compliance
  • ALCOA+ data integrity principles
  • OOS and OOT investigation experience
  • GMP and GLP knowledge
  • Method validation and transfer

Nice-to-have

  • Strong critical thinking skills
  • Excellent documentation abilities
  • Cross-functional collaboration experience
  • Root cause analysis expertise
  • Vendor audit capabilities

Key Requirements

  • Degree in Pharmacy, Chemistry, or Pharmaceutical Sciences
  • Experience in QC, Analytical Development, or QA
  • Knowledge of cGMP and SOPs

Work Rights

Not specified

Tailored Resume

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