Quality Assurance Lead

3 weeks ago


Sonipat, India Crystal Crop Protection Limited Full time

Key Responsibilities:

  1. To review the study plan/amendment/SOPs as per compliance with principles of GLP. This review is to be documented.
  2. To maintain copies of all approved study plans and their amendments and Standard Operating Procedures (SOPs) in use in test facility.
  3. To conduct inspections to verify that all studies are conducted according to GLP principles. This inspection also should verify that SOPs and study plan are available with study personnel.
  4. Three types of inspection are to be conducted viz. i) study based ii) facility based and iii) process based. Records of all inspections are to be retained and archived.
  5. Review of final report to confirm that methods, procedures and observations are accurately and completely described, and the reported results reflect completely the raw data of the study. Accordingly, a statement is to be issued and to be delivered along with a study report.
  6. Ensure, compliance of OECD principals of GLP, project life cycle management, risk-based assessments, and fully complied document no 17, 22,23 and 24.


Qualifications:

  • Education: Master’s degree in chemistry.

Experience

  • Essential: QA experience in Pharmaceutical or Agrochemical.
  • Preferred: Experience of QAU in an OECD GLP laboratory.



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