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QA Compliance Officer

Posted 18/08/2021
£29,355 per annum
Porton
Full time


QA Compliance Officer
Permanent
37.5 hours per week
Porton
Salary Circa £29,355 DOE


Company information:

Company client is a medium sized life-science company performing a range development and manufacturing roles for biopharmaceuticals. This also includes all associated support functions from logistics through to engineering, quality control / quality assurance, regulatory affairs, and management. The position is based in the Quality Department where several key activities are undertaken to deliver compliance and continuous improvement across PBL. The immediate team is responsible for internal audits and supplier audit management programmes.


Key responsibilities, but not limited to:

QA Compliance Officer, supported by the Senior Compliance Officer, will be responsible for:
·        Ensuring all work complies with guidance set forth in EU and US FDA GMP regulations governing the manufacture, storage and distribution of medicinal products;
·        Internal and external (supplier) audits including organising, planning, performing, reporting and review of evidence;
·        Raising, investigating and closing out CAPAs;
·        Ensuring supplier questionnaires are satisfactorily completed on time by key manufacturers and suppliers;
·        Liaising with suppliers to obtain relevant information for their approval to provide key materials and services to PBL;
·         Approval of GMP monographs;
·         Producing technical agreements for the supply of goods and services from   critical suppliers;
·        Initiate and progress supplier complaints; 
·        Maintain the supplier monitoring database and associated spreadsheets for tracking; 
·        Assisting QA overview of manufacturing and testing areas; 
·        Providing input to KPI reports for the team; 
·        Undertaking relevant training 
·        Undertaking work in accordance with PBL health and safety policies and procedures. 


Person Specification:
·         Have current right to work in the UK;
·        A good standard of written and spoken English language
·        Educated to degree level or HND in a relevant subject or equivalent level of experience of working at a similar level in specialist area
·        Experience in operating quality systems in GMP environment
·        Experience in auditing in GMP
·        Excellent time management and experience of working to deadlines
·        Working knowledge of GMP, GCP, GLP, GDP and/or ISO
·        Ability to multitask and prioritising workloads
·        Ability to communication at all levels



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