Title: QC Lead
Location: Darlington, County Duhram
Salary: £35,000 - £43,000 per annum with a really attractive benefits package
SRG are currently working with a very well-established organisation, which is responsible for technical innovations across the UK in different scientific sectors including pharmaceuticals and biologics, who are currently looking to further expand their quality department.
As the organisation have recently developed a brand new GMP manufacturing facility, the main focus of this role is to set up and run the QC and Analytical Lab to support development and routine GMP analysis.
This organisation is a leader in scientific innovation, mainly looking at providing scientific support around process, development and product improvement working across multiple sites. Founded in 2004, they have been behind some of the UK's biggest scientific innovations.
- To understand the state-of-the-art of tools and knowledge in the application of analytical science in the Pharmaceutical sector
- To design, validate and utilise analytical methods for characterisation of pharmaceuticals.
- To perform analytical characterisation of pharmaceuticals and data analysis to the highest standards and is delivered in compliance with GMP quality certification.
- Support/supervision of other Quality Control Analysts and Technicians providing strong technical leadership, direction and continuous development opportunities.
- Qualification, calibration and monitoring of analytical equipment.
- Manage outsourced QC activities with third parties.
- Support the site Pharmaceutical Quality System including input into investigations and/or CAPAs.
- Perform laboratory investigations and out of specification investigations to GMP standards.
- In-depth knowledge and practical experience in the development and application of analytical techniques and methodologies for characterisation methods of biological products and cleaning studies including and not limited to UPLC/HPLC, qPCR and UV Photometry.
- Hands on experience of analytical chemistry or microbiology techniques preferred.
- Knowledge of ISO 9001 quality management systems and standards.
- Knowledge of EU GMP Guidelines, including Annexes 1, 2 & 15.
- Experience in the use and implementation of electronic document management systems and QMS.
To apply click the link or send your CV to firstname.lastname@example.org
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