Quality Assurance Lead
3 weeks ago
Key Responsibilities:
- To review the study plan/amendment/SOPs as per compliance with principles of GLP. This review is to be documented.
- To maintain copies of all approved study plans and their amendments and Standard Operating Procedures (SOPs) in use in test facility.
- 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.
- 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.
- 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.
- 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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