QC Manager // Laboratory Manager
Time to join a rapidly expanding biopharmaceutical organisation and lead a spcialist GMP analytical chemistry laboratory.
Title: QC Manager
Status: c£38K plus excellent benefits
Contact: Alex Butcher
Reference No: 229280
This position has become available due to continued expansion at our clients biotechnology facility.
To lead and manage a specialist GMP analytical chemistry/biochemistry laboratory to provide compliant testing of licensed pharmaceutical products
The candidate must have:-
* Strong history of working within a GMP QC environment preferably but not restricted to Biopharmaceuticals, small molecule will be acceptable. The department has more of a chemistry direction rather than Biochemistry.
* Strong GMP skills
* Good staff management skills.
* Good understanding of a variety of suitable analytical techniques.
* A history of dealing with non conformances, OOS investigations, new method validations and transfers.
* Validation of analytical methods and stability studies to ICH Q1 and Q2
* Knowledge of ICH Q3, Q5, Q6 & Q10
* Experience of hosting regulatory audits
* Experience of continuous improvement
The successful candidate will be responsible for two or three teams within QC. The QC teams cover Raw Materials, Chromatography, Enzyme analysis (protein, activity, catalytic constants, KF, physical testing), Water testing and compliance and trending. Each team consists of a Senior Analyst and two or three Analysts.
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