- Performs analytical testing activities in relation to method
validation and technical transfer activities to ensure that all
methods meet ICH, USP and EP guidelines
- Trains other QC analysts in laboratory methods and procedures
- Executes validation, operation, maintenance, calibration and
troubleshooting of equipment and its associated software.
- Writes, executes, reports and reviews IQ/OQ and PQ protocols to
ensure that all relevant equipment is qualified for cGMP use.
- Performs routine and non-routine analytical testing activities.
- Review and approval of laboratory test results.
- Ensures that testing and results approval are completed within
agreed turnaround times.
- Writes and reviews laboratory TMs, SOPs and WIs as directed by
- Ensures QC activities are carried out in compliance with product
license commitments, cGMP and company quality standards.
- Deals with non-conformances/ deviations in an accurate and
- Deputizes for the QC Team Leader as appropriate.
- Maintains and develops knowledge of analytical technology as
well as cGMP standards.
- In process control testing and activities to support the production
- A third level qualification of a scientific/technical discipline is required.
- Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
- Builds strong productive relationships.
- Demonstrates ability to work with teams and individuals
- Asserts personal ideas and opinions using persuasion to influence others
- Seeks opportunities to grow and develop professionally
- Uses best practices to improve business operations
- Holds self-accountable for compliant and flawless execution
- Takes personal responsibility for decisions that successfully build customer value
- Effectively manages and adapts to change
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The Life Science Specialists