Quality Control Auditor x2 - Greater Manchester

Recruiter
CK Clinical
Location
Salford
Salary
£22000 to £28000
Posted
16 Feb 2017
Closes
16 Mar 2017
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Victoria Walker is currently recruiting for 2x Quality Control Auditors to join a leading testing provider on a permanent basis at their office in Greater Manchester. Please note this is an office based position with a high level of autonomy.

The company has a network of state-of-the-art, highly regulated laboratory facilities based in the UK, providing analytical services to customers in the pharmaceutical and healthcare sectors. With worldwide reach, they deliver expert support to their clients. These Quality Control Auditors will perform data integrity audits and checks for GLP, GMP, GCP and non-GxP data as necessary to assure data integrity. While 2x experienced auditors with analytical experience would be preferred, the company may consider taking on 1x experienced auditor with analytical experience and 1x experienced analytical chemist who is keen to develop their auditing skills. The company is offering a salary in the region of £22-28,000pa for this role depending on skills and experience and the benefits include 25 days holiday, pension scheme, flexitime, promotional opportunities, cycle to work scheme, child care vouchers and
more.

Further responsibilities of these Data Integrity Quality Control Auditors will be to:
-perform GLP, GMP, GCP and related quality system audits necessary to assure compliance with all relevant current National and International Quality Standards and customer requirements
-assist the Quality Assurance Senior Team Leader in the overall implementation of the Quality function
-check/ audit analytical technical data, associated records, facility and operational systems, to monitor and assure management of data integrity/ compliance with all relevant regulatory requirements
-provide general support to all Quality Unit activities relating to GLP, GMP, GCP, and other similar Quality Systems established in order to ensure that the appropriate standards and effective working systems and relationships are maintained and where necessary improved
-schedule and inspect GLP study procedures and related facilities to ensure compliance with regulatory requirements and identify and report any areas of non-compliance to both study and facility Management
-audit and/or Review GMP validation reports, C of As, test certificates, data for batch release etc to ensure that they are internally consistent, accurately and completely reflect the raw data and meet current Good Manufacturing Practice standards and regulations
-audit and/or Review GCP reports, C of As, test certificates, data for analysis of samples from clinical trials etc. to ensure that they are internally consistent, accurately and completely reflect the raw data and meet current Good Clinical Practice standards and regulations
-identify and contribute to areas for improvement within the quality management systems to ensure compliant and efficient systems
-assist in monitoring of the Automated Systems Qualification program, providing advice and guidance where necessary
The successful QC Auditor will have the following qualifications, skills and experiences:

For the experienced auditor(s) with analytical experience:
-Ideally degree qualified in BioChemistry or Chemistry (or related scientific discipline)
-A sound working knowledge of GLP, GMP, GCP and other analytical related quality standards
-Proven industry experience of performing detailed audits for data integrity within the above regulatory framework
-Industry experience in analytical science (chromatographic methods e.g. HPLC, GC, LC etc. and/ or other pharmaceutical characterisation techniques)

For the experienced analytical chemist:
-Ideally degree qualified in BioChemistry or Chemistry (or related scientific discipline)
-Considerable industry experience in analytical science (chromatographic methods e.g. HPLC, GC, LC etc. preferred but other pharmaceutical characterisation techniques considered)
-A sound working knowledge of GLP, GMP, GCP and other analytical related quality standards
-The willingness and ability to perform detailed audits of this data

CK Science is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference SH38269 in all correspondence.