Executive Analytical QA | Global Calcium | Hosur, Bangalore

Job Description

Roles and Responsibilities

Job title: Executive AQA

Experience: 6 to 8 years of experience in QC and QA.

Education: MSc Chemistry( perf organic chemistry).

NOTE: Male Candidate only.

  • Experience in QC activities i.e. Analysis of API (Wet and instrument)
  • Calibration of critical analytical instrument i.e. HPLC, GC. ICP-OES, IC, AAS, LC-MS, Stability Chamber, etc.
  • Experience in method validation e.g. in related substance, assay content, and elemental impurities as per regulatory guideline (ICH)
  • Experience in preparation, reviewal, and approval of QC documents i.e. specification, test method, analytical test report, stability study report, and method validation report.
  • Knowledge of General chapter requirements as per monograph. E.g. USP, BP, EP, IP
  • Knowledge of review and approval of computer system validation report of the analytical instrument as per 21 CFR Part II requirement or GAMP5 requirement.
  • Experience in reviewing and approving QMS documents related to QC i.e. OOS, OOT, Change control, Deviation, and Laboratory incident.
  • Experience in reviewing and approval of analytical instrument audit trails as applicable. (HPLC, GC, ICP-OES, IC, AAS. LC-MS)
  • Experience in handling customer audits and exposure to regulatory audits will be preparable.

Qualification: MS/M.Sc Chemistry