Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Pharmiweb.com RSS Feed PharmiWeb Candidate Blog

Pharmiweb.com RSS Feed PharmiWeb Client Blog

Job Details

Validation Consultant

Company: Thornshaw Recruitment
Location:
Reference: TD9182
Closing Date: 02 Jan 17
Type: Permanent
Salary (£): On Application
Benefits:

Job Summary:

Our client, is a consultantcy company working directly for the pharmaceutical market. They now have a requiement for a QA & Validation consultant to work with one of their top global pharmaceutical clients.

Requirements:

Our client, is a consultantcy company working directly for the pharmaceutical market.   They now have a requiement for a QA & Validation consultant to work with one of their top global pharmaceutical clients.

Summary
•    The successful candidate will become a Quality Assurance Validation Consultant in their life sciences compliance consulting business.
•    The contract term is 6 months. Subsequent contracts are dependent on business conditions and candidate performance.
•    You will join a small team that is focussed on Computerised System/IS compliance for a global top 20 pharma client 
•    The successful candidate will be educated to a minimum of B.Sc. level, and will have a minimum of three years working in a regulated pharmaceutical GxP environment in some or all of the following areas: quality assurance, computer system validation, information technology.
•    The success of our business depends on continually exceeding client expectations, and it is against this standard that candidates will be measured.

Responsibilities
•    Provide consultancy and support in the assurance of regulatory compliance for computer systems, computer system validation and IT processes.
•    Schedule and carry out periodic reviews of computerised systems
•    Support the data integrity program for the site.
•    Development and review of validation documentation and procedures.
•    Provide consultancy and support for QC/QA IS related business as usual computer system activities and projects. 
•    Participation in the change management process for computerised systems
•    Track and manage to closure: Quality System Deviations, risks, issues, and audit observations.
•    Support QA with the development of effective relationships with GMP process owners, GMP computer system owners, service providers.
•    Partake in and provide support to the client during customer audits and regulatory inspections;
•    To collect new developments in external GMP requirements for computer system validation and IT compliance and to train relevant personnel as appropriate.
•    Actively participate in operational excellence initiatives. 
•    As/if a need arises, participate in audits of service providers and other third parties to assess compliance with pharmaceutical regulations and client policies and standards.
•    As/if a need arises, perform formal, structured assessments of computerised systems against client policies and standards.

Experience
•    Minimum 3-5 years pharmaceutical industry experience, in an IMB and/or FDA regulated (GxP) environment.
•    Knowledge and experience of GAMP 5 or equivalent models. 
•    Knowledge and experience of data integrity requirements. 
•    Experience of working in an outsourced IT services environment.

Summary
•    The successful candidate will become a Quality Assurance Validation Consultant in their life sciences compliance consulting business.
•    The contract term is 6 months. Subsequent contracts are dependent on business conditions and candidate performance.
•    You will join a small team that is focussed on Computerised System/IS compliance for a global top 20 pharma client 
•    The successful candidate will be educated to a minimum of B.Sc. level, and will have a minimum of three years working in a regulated pharmaceutical GxP environment in some or all of the following areas: quality assurance, computer system validation, information technology.
•    The success of our business depends on continually exceeding client expectations, and it is against this standard that candidates will be measured.

Responsibilities
•    Provide consultancy and support in the assurance of regulatory compliance for computer systems, computer system validation and IT processes.
•    Schedule and carry out periodic reviews of computerised systems
•    Support the data integrity program for the site.
•    Development and review of validation documentation and procedures.
•    Provide consultancy and support for QC/QA IS related business as usual computer system activities and projects. 
•    Participation in the change management process for computerised systems
•    Track and manage to closure: Quality System Deviations, risks, issues, and audit observations.
•    Support QA with the development of effective relationships with GMP process owners, GMP computer system owners, service providers.
•    Partake in and provide support to the client during customer audits and regulatory inspections;
•    To collect new developments in external GMP requirements for computer system validation and IT compliance and to train relevant personnel as appropriate.
•    Actively participate in operational excellence initiatives. 
•    As/if a need arises, participate in audits of service providers and other third parties to assess compliance with pharmaceutical regulations and client policies and standards.
•    As/if a need arises, perform formal, structured assessments of computerised systems against client policies and standards.

Experience
•    Minimum 3-5 years pharmaceutical industry experience, in an IMB and/or FDA regulated (GxP) environment.
•    Knowledge and experience of GAMP 5 or equivalent models. 
•    Knowledge and experience of data integrity requirements. 
•    Experience of working in an outsourced IT services environment.

Apply for this job: Validation Consultant

Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

Advertising
Share | | |
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.