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Job Details

Quality Analyst Medior

Company: ProClinical Ltd
Location: Oxford
Reference: QA.CM.17452
Closing Date: 25 Jul 18
Type: Contract
Salary (£): Negotiable
Benefits:

Job Summary:

ProClinical is seeking a Quality Analyst Medior for a Healthcare solutions company, to be based in Oxfordshire on a Contract basis.Job Responsibilties: * Responsible for release of product from the system. * Responsible for supporting production in the review and post compounding check operations. * Responsible for implementation and management of the company quality system within the compound unit. Ensuring regulatory compliance. ...

Requirements:

ProClinical is seeking a Quality Analyst Medior for a Healthcare solutions company, to be based in Oxfordshire on a Contract basis.

Job Responsibilties:

* Responsible for release of product from the system.
* Responsible for supporting production in the review and post compounding check operations.
* Responsible for implementation and management of the company quality system within the compound unit. Ensuring regulatory compliance.
* Ensure that unit is compliant with all corporate quality system policies and procedures.
* Responsible for review of the implementation of the company Quality System to initiate, and drive continuous improvement
* Responsible for the Review of prescriptions on Merlin
* Responsible for release activities associated with products manufactured at the compounding units.
* Ensure that a schedule of environmental monitoring is in place that complies with GMP and that any out of limits or alerts are investigated and actions taken to correct.
* Investigation of out of limits results using exception and CAPA processes
* Ensuring all measuring equipment that may have an impact on product quality are calibrated to traceable standards
* Ensure outcomes, decisions and actions of the review are documented
* Ensure meeting actions are completed to agreed deadlines
* Track and trend on a monthly basis quality system data and indicators, including but not limited to Exceptions, Errors and Complaints. Trending should include timeliness in completion as well as actual numbers
* Ensure that any failure to follow procedure or failure of product to meet specification is fully documented and investigated
* Review and approval of exception reports
* Leading and coordinating investigations in the cause of exceptions
* Regularly communicates with all site staff regarding quality issues and promotes the quality system as a business process for improvement of customer satisfaction and regulatory compliance
* Ensures staff understand their responsibilities under the quality system regulations
* Communicates changes of the quality system to staff, ensuring appropriate training programs are executed.
* Ensures all procedures are controlled and current versions are available to staff as required
* Ensures there are no unauthorized changes to documents including creation of local documentation.
* Ensures all quality records are reviewed and that they are complete, comprehensive and legible and comply with good documentation practice.
* Ensures are quality records are retained in such a way that they remain complete, comprehensive and legible

Skills and Requirements:

* Science degree e.g. Pharmacy, Chemistry, Microbiology or equivalent
* BTech- Pharmaceutical Science or equivalent work experience
* English GCSE or equivalent

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Caleb Mensah on +44 203 854 1080 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Apply for this job: Quality Analyst Medior

Contact Information:

Address:  ProClinical Ltd
Eldon House Eldon Street London
EC2M 7LS
England
Tel:  0800 988 4437
Fax:  +44 (0)207 834 9470
Website:  Visit Our Web Site

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