Job Description

Medical

Senior QC Analyst

Location:
Porton
Salary:
£28,000 - £32,000 Per Annum
Job Requirements/Description
Senior QC Analyst Location: Porton Salary: £28,000 - £32,000 Type: 12 months FTC The company Our client has approximately 400 staff, performing a range of process and analytical development, production, quality control and quality assurance roles associated with the development and manufacture of biopharmaceuticals. The department carries out the manufacture of Erwinase and Anthrax Vaccine, as well as contract manufacturing projects. The role To supervise and schedule work for the QC Analyst. To undertake chemical and biochemical analyses to support the manufacture of licenced pharmaceutical products. Ensure all work performed within the laboratories is carried out in compliance with corporate statutory health and safety requirements. Main Duties * Write quality documentation relating to raw materials, water and product testing * Deputise for the QC First Line Manager when required * To supervisor junior QC Analytical staff * To schedule work for the QC Analytical staff to ensure manufacturing deadlines are met * Ensure analysis and recording of QC and stability testing has been performed in compliance with the statutory requirements of cGMP * Responsible for testing raw material, in process and finished product samples to ensure that they meet the specifications established in the product licence and internal specification document * Writing Standard Operating Procedures and their associated risk assessments to ensure that those tasks are performed safely * Organise and liaise with external testing laboratories to arrange correct and on time testing to meet production deadlines * Maintain up-to-date awareness of regulatory & scientific developments via courses, meetings, and literature * Responsible for the verification of analytical raw data and release results from the QC Analytical department * Responsible for writing quality records such as non-conformances, CAPAs and change control * Responsible for managing equipment in line with the QC department and introducing new equipment into the QC department including completion of the associated quality records such as User Requirement Specifications, System Impact Assessments, IQ, OQ, PQ, Validation Summary Reports, Calibration and Maintenance Schedules * Maintenance and calibration of equipment. * Purchasing equipment for the QC department * Undertake work in accordance with Code of Safety Practice and Quality Systems * Monitor compliance, identify weaknesses and develop strategies to continue to improve systems * Organise and liaise with internal departments such as validation, pharms stores and QA where required * Write transfer/validation protocols, executing protocols in the laboratory and writing the reports needed Essential Skills Required * Degree in Chemistry/Biochemistry or other suitable degree * Knowledge/experience of cGMP, EP, and USP * Knowledge/experience of ICH requirements * Work experience in similar laboratory * Experience of the out of specification process and carrying out laboratory investigations * Previous experience of supervising staff * Excellent communication skills, both verbally and written in relation to technical issues * Problem Solving * Adaptable to change * Able to work on own initiative * Logical troubleshoot QC analysis * Attention to detail
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