Knowledge and exposure to WHO guidelines, practices and product filing.
Expert in QMS documentation
Expert in Qualification and Validation
Exposure on Audit as member to facing auditors.
Preparation and review of validation protocols and reports.
Knowledge of Quality control GLPs and Lab coordination.
Handling stability studies as per the regulatory requirement.
calibration and maintenance programs, master documentation, batch documentation, technology transfer etc.
To extend the support to Regulatory Affairs in preparing the analytical data as per their requirements for registration of products in different countries.
Responsible for coordinating with other departments like stores, QC, Maintenance, purchase department, Process development lab in day to day activity for better operational requirements and to follow the cGMP requirements
Responsible to prepare the weekly and monthly reports and act accordingly to fulfill the quality assurance requirements
Should have sound knowledge of all QA documentation
To ensure that all the records are retained as per the requirement.
Salary: Not Disclosed by Recruiter
/ Clinical Research
Functional Area: Production
Role Category: Production/Manufacturing/Maintenance
Role: Quality Assurance/Quality Control Executive
Employment Type: Full Time, Permanent