- Achieves competency in CBIL laboratory methods and procedures.
- Trains other QC analysts in laboratory methods and procedures when required.
- Performs Microbiological and/or Chemical testing activities in relation to method validation and technical transfer activities so as to ensure that all methods meet ICH, CFR and USP guidelines.
- Executes testing activities as specified in IQ/OQ and PQ protocols to ensure that all relevant equipment is qualified for cGMP use.
- Performs routine Microbiological and/or Chemical testing activities during Plant production phase.
- Reviews laboratory test results when required.
- Ensures that testing and results approval are completed within agreed turnaround times.
- Writes and reviews laboratory SOPs as directed by company policy.
- Ensures QC activities are carried out in compliance with product licence commitments, cGMP and company quality standards.
- Is an active member of the QC group and provide assistance with other group activities as required and communicates relevant issues to the QC Team Leader.
- Anticipates and plans for future requirements in the area.
- Deputises for the QC Team Leader as appropriate.
- Maintains and develops knowledge of analytical technology as well as cGMP standards. This is not an exhaustive, comprehensive listing of job functions. May be required to perform other duties, as the project requires
- BSc (Honors) in a scientific/technical discipline.
- Analytical skills required to troubleshoot laboratory issues.
- Customer focus and result driven.
- Efficient and flexible.
- Excellent communication skills.
- High attention to detail.
- Ability to work well within team structures and provide leadership as required.
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The Life Science Specialists