Senior Quality Assurance Officer

Key People


Job ID :

13171


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,--Cambridge,Cambridge,


Key Skills :

quality, quality assurance, consultant, GVP, PV, pharmacovigilance, drug safety


Salary :

£35000 - £45000 per annum + benefits


Date Posted :

08 Oct, 2018



Company Name :

Key People


Location1 :

Cambridge




Job Category :

Quality Assurance Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

An excellent opportunity has arisen for an experienced PV/QA Officer to join a leading consultancy on a permanent basis. You will ideally have a strong PV and QA background, with between 2-6 years of experience.

Primary Responsibilities
*Management and oversight of Quality Management System
*Management and oversight of Corporate audit programme
*Conduct of internal GVP audits and external service provider audits
*Support and preparation of client audits and regulatory inspections
*Management of internal and external audits and inspection findings and associated CAPAs
*Review and feedback on responses to client audit findings and regulatory inspection reports
*Maintaining a strong working knowledge of SOPs as well as ICH, GCP,GVP, local regulations and guidelines
*Recommend, develop and maintain the controlled document system including SOPs, WPDs and any associated forms and templates
*Provide Heads of Practice with quality verification and oversight including corrective action plans for activities not meeting quality standards
*Collaborate effectively with all employees as required
*Oversee, maintain and improve training
*Support and maintain quality activities for oversight of service providers to ensure they are functioning appropriately and audit as required

Education and Experience
*Bachelor's or higher graduate degree in a science related field or equivalent experience
*5 + years of experience within a quality and/or pharmacovigilance role
*Proven experience within a quality and/or pharmacovigilance role
*Previous experience of managing non-conformance/CAPA systems desirable

Key skills
*Quality focus
*Deadline-driven, pro-active approach
*Process orientated with outstanding attention to detail
*Effective oral and written communication skills
*Excellent English Language (Orla and written) required

Technical Knowledge
*European/Global Pharmacovigilance Regulations
*GVP Guidelines
*GCP Guidelines
*Microsoft Office

Core Competences
*Team orientated attitude
*Excellent organisational and interpersonal skills

For further details about this role, or other vacancies within Quality Assurance or PV, please contact Tim Barratt on +44(0)1727 817 626 or email tbarratt@keypeople.co.uk


Company Name:

Key People


Headquarters:

Catherine House,Adelaide Street


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

AL3 5BA


Website:

www.keypeople.co.uk


Employees:

less than 100


Industry:

Pharmaceutical


City:

St Albans


Phone No. :

01727 817 626


Key People is a recognised leading supplier of staffing and recruitment services to the Pharmaceutical, Scientific & Biotech industry. The company has been operating for over 20 years and has an integrated team of qualified recruitment consultants averaging more than 7 years of recruitment experience. Each consultant is a specialist recruiter for their market area, so they can provide full market advice to candidates and clients alike.

For more information,visit www.keypeople.co.uk.

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