Due to the nature and training requirements of this role, applicants must have the legal right to work in the UK, We are unable to provide Visa Sponsorship for this role.

Requirements

• To co-ordinate, schedule and execute raw material, stability and in process real-time analytical laboratory testing.
• Provide technical expertise in analytical procedures that may include Haemagglutination Assay, Protein Assays, ELISA, Cell Culture, Plaque Testing, pH testing, Osmolality testing, TVC testing.
• Apply cGMP work-practices and techniques to test and release raw materials and intermediate products.
• Ensure that all QC analysts are appropriately trained and competent in the procedures they are conducting and are following cGMP working practices at all times.
• Be responsible for the development, collating and reporting of key quality and business metrics, and use such metrics to drive a culture of continuous process improvement within the area of responsibility.
• Conduct on-time reporting according to the defined and trained document management standards including review and verification of analytical data provided by the QC Technicians.
• Immediately escalate and report any deviations to materials, facilities, processes or procedures to the Manager.
• Be accountable for the analytical laboratories being clean, tidy and well organised and in a state of continuous inspection readiness.
• Manage the daily maintenance of laboratories and equipment required to adequately support routine laboratory activities.
• Write QMS documentation including SOP's, OOS/OOT, Change Control, Deviations, CAPA's.
• Represent QC in cross-functional planning, batch release and project meetings.
• Provide support as an Analytical Subject Matter Expert (SME) as required.
• Identify areas for continuous improvement and escalate those to the QC Manager.
• Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative environment within the team-setting.
• To undertake any other duties as requested by the line manager in accordance with company requirements.
• Contribute, encourage and support staff development activities.
• Support out of hours real-time testing, adapting to the production schedule.
• Evenings/weekend work as required to support production schedule (Additional shift allowance).
• ExperienceWorking within a QC laboratory environment, working to GMP within a recognised quality system
• Ability to prioritise, organise and schedule work within a busy laboratory  
• Experience of writing and working to SOP documentation 
• Extensive QMS experience, OOS, Change Control, Deviations. 
• Experience in biological assays. 
• Experience in reference standard management. 
• Experience driving a team to achieve individual, team and organisational objectives. 
• Experienced in relationship handling with external bodies, such as suppliers,  regulatory and audit authorities. 
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