Company: TC BioPharm
Closing Date: 09 Dec 16
Type: Full Time
Salary (£): Competitive
Benefits: Excellent, comprehensive and flexible
A superb opportunity to join an emerging cancer immunotherapy company developing cell based treatments. The role is based at their manufacturing facility in the central belt of Scotland.The company is looking to recruit a Quality Auditor to report to the Senior Project Manager.
Quality Auditor – Cancer Immunotherapy (Central Belt of Scotland)
The post holder will be responsible for ensuring that operations on site are being conducted according to all internal and external quality and regulatory compliance requirements. The successful candidate will have previous experience in a quality assurance position within a Pharmaceutical/Biotechnology company, and must have a proven GMP background, experience of quality documentation systems and performing internal/external audits. The successful candidate will be responsible for overseeing correction and remediation activities affecting the quality system such as data quality issues, oversight of root cause analysis, developing QA procedures and executing them successfully.
Aligned to the business, this role is as diverse as it is essential, and this challenging opportunity requires you to adopt a hands-on operational approach, and at the same time influence strategic decisions together with coordinating wide-ranging process improvement projects.
Key responsibilities will include:
· Perform data integrity audits/ checks for GMP, GCP and non-GxP data compliance as necessary to assure data integrity.
· Perform GMP, GCP and related quality system audits necessary to assure compliance with all relevant current National and International Quality Standards.
· To assist the Senior Project Manager in the overall implementation of the Quality function necessary for the maintenance of the quality management systems and related activities.
· Review data sets in accordance with data integrity procedures for GMP, GCP and non-GxP data as necessary to assure data integrity.
· Provide general support to all Quality Unit activities relating to GMP, GCP, and other similar Quality Systems established within the company in order to ensure that the appropriate standards and effective working systems and relationships are maintained and where necessary improved throughout the company.
· Schedule and inspect GMP study procedures and related facilities to ensure compliance with regulatory requirements and identify and report any areas of non-compliance to both Laboratory and facility Management.
· Audit and/or Review GMP validation reports, CoAs, 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, CoAs, 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.
· To identify and contribute to areas for improvement within the quality management systems to ensure compliant and efficient systems.
· Ensure that instrument records are reviewed and QA records are maintained.
· Provide input into the enhancement of quality policies, systems and procedures as appropriate.
· Responsible for ensuring the integrity of the company’s manufacturing group’s QMS and processes to support cost effective provision of product and services.
· Responsibilities for tracking the completion of Deviations, Investigations, CAPA's and Change Controls.
· Participating in scheduled internal and Global Compliance Audits.
· Managing the internal audit programme for the site.
The successful candidate will be:
Computer literate and experience using "Windows" computer software applications such as Word and Excel. Excellent oral and written communication. Ability to proof read
Experience with Scientific and/or Pharmaceutical terms.
Extensive knowledge of GxP and related practices for the manufacture of active pharmaceutical products.
Inspection experience of hosting audits and regulatory authority inspections.
Relevant QA experience in the Pharmaceutical industry.
Typically educated to a BSc or equivalent in a relevant scientific subject or direct relevant experience will also be considered.
Previous experience of working within quality driven systems and/or a regulated environment. (GxP)
Experienced in performing data audits and approval of completed manufacturing or testing documentation.
Planning & Organisational
Strong organisation, time management skills and the ability to deliver results.
Able to work with the production schedule and plan accordingly.
Able to adapt to changes in schedule and respond accordingly in order to issue current, effective documentation.
Interpersonal & Communication
Excellent interpersonal skills are required as this position requires daily contact with our internal departments.
· Teamwork is essential as coordination between Quality Assurance and Operational personnel is mandatory.
This is a superb opportunity to join a leading organisation in a key role.
2 Parklands Way,
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