JOB PURPOSE:
To perform pharmaceutical microbiological procedures in compliance with FDA regulations and other regulatory/audit groups in order to ensure the accuracy of test results and raw data generated.
KEY ACCOUNTABILITIES:
Policies, Processes & Procedures:
- Follows all relevant departmental policies, processes, standard operating procedures and instructions so that work is carried out in a controlled and consistent manner.
Day- to-day operations:
- Follows the day-to-day operations related to own job to ensure continuity of work.
Job Specific Accountabilities:
- Implement standard operating procedures.
- Perform all the desired Microbial tests.
- Follow cGMP and safety precautions.
- Follow the documentation system requirements.
- Perform calibration for instruments.
- Perform environmental monitoring tests for plants.
- Perform sampling for water testing.
- Perform method validation for Microbiological tests.
- Handling pharmaceutical waste in micro lab.
Continuous Improvement:
- Contributes to the identification of opportunities for continuous improvement of processes and practices taking into account ‘international best practice’, improvement of business processes, cost reduction and productivity improvement.
Reporting:
- Assists in the preparation of timely and accurate reports of quality to meet company and department requirements, policies and standards
Safety, Quality & Environment:
- Complies with all relevant safety, quality and environmental management policies, procedures, and controls to ensure a healthy and safe work environment.
Related Assignments:
- Performs other related duties or assignments.