Senior QC Analyst
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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