Senior QC Analyst


Premium Job From BCT Resourcing

Recruiter

BCT Resourcing

Listed on

23rd July 2021

Location

Porton

Salary/Rate

£28000 - £32000

Type

Contract

Start Date

2021-07-22 10:04:04

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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

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