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Key member of Site Leadership Team (SLT). Works with Site Senior Leadership Team to develop site strategy, implement site performance KPI’s, and translate these into specific annual performance goals
Overall responsibility for Argenta’s Quality Control performance including testing of starting materials, finished products, stability samples, validation samples, data review and investigations
Implements safe and GMP compliant working practices in the function, and ensures team perform their duties accordingly
Lead the development of Argenta’s Quality Control systems, ensuring on time delivery of valid results
Drive staff engagement and a positive culture within the Quality Control department to achieve high-performing results
Grow, develop and support your leaders and extended analytical staff
Demonstrate leadership on quality, compliance and HS&E culture
Management of QC budget
Drive improvements in operational quality performance to enhance the customer experience and minimise the 'cost of poor quality'
Provide QC support for analytical method transfers and Validation, ensuring a smooth introduction of new analytical methods, timely generation of data and ensure transfer documentation (protocols and report) are appropriately supported
Requirements
Bachelor's degree in Science (Chemistry
Pharmacy
Biology) or equivalent experience
MSc. in Science, Pharmacy or Chemical Engineering, Pharmaceutical Technology or equivalent experience
Minimum 5 years experience leading a QC laboratory function within a Pharmaceutical business with advanced knowledge of relevant cGMP requirements
Experience in various analytical techniques, including method development, validation and transfer, wet chemistry and instrument techniques, chromatography systems and microbiological testing
Well-developed leadership skills, with a proven track record of leading teams, performance management, and coaching
Excellent interpersonal, written and verbal communication skills
High energy and commitment to company values
Commitment to continuous improvement and driving efficiency
Technical writing skills e.g. reports
SOPs and change control
Proven ability to evaluate and produce reliable results, troubleshoot, and problem solve complex problems