Participate in the preparation, operation and completion of assigned process stages to ensure the production of bulk drug substances is within establish timing and quality standards.
Ensure good housekeeping of the facilities to keep them in good operational order in line with cGMP, safety and environmental requirements.
Identify areas for improvement and participate in continuous improvement projects to enhance operational effectiveness and efficiencies
Participate in commissioning and qualification activities as required
Perform timely review of documentation and make necessary corrections.
Have good quality mindset and integrity to ensure products are manufactured with the highest quality
Participate in deviation investigation process
Reporting and documentation
- Ensure that batch record, checklist and logbooks are correctly recorded, cGMP complied and maintained
- Perform VS review of completed documentation to ensure adherence to GDP
Requirements:
Possess (NITEC/HIGHER NITEC/DIPLOMA) in the fields of Biotechnology/Chemical Engineering/Life Science
Minimum 2 years of relevant experience in Biologics/Chemical/Pharmaceutical/ Food or other regulated industry
Basic knowledge of cGMP
Familiar with purification/fermentation/conjugation/isolator operations/material and buffer operations is an advantage
Candidates with no prior experience will be considered
Able to perform 12 hours shift and in clean room environment
Comfortable to perform physical work
To help us process your application, please visit www.gmprecruit.com to upload your resume on our website. GMP Technologies (S) Pte Ltd | EA Licence: 11C3793 | Fiona Koh | Registration No: R1109239