- Achieves competency in laboratory methods and procedures.
- Performs analytical testing activities in relation to material release.
- Performs routine and non-routine analytical testing activities.
- Review and approval (where appropriate) 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 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 and Manager.
- Deals with non-conformances/ deviations in an accurate and timely manner.
- Maintains and develops knowledge of analytical technology as well as cGMP standards.
- A third level qualification in a scientific/technical discipline required, ideally Microbiology based.
- Knowledgeable of FDA/EMEA regulatory requirements applicable to pharmaceuticals.
- Demonstrated knowledge and testing experience in an FDA/HPRA approved QC laboratory.
- A minimum of 2 years' experience in a laboratory-testing environment within the pharmaceutical industry would be an advantage.
- Builds strong productive relationships
- Demonstrate 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
- Works effectively with people that have diverse styles, talents and ideas
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
Fastnet - The Talent Group
'Not Just Placers.........Partners'
The Life Science Specialists