Quality and Compliance Supervisor
Broughton Laboratories has a unique opportunity available for a Quality and Compliance Supervisor to join the team in Skipton, North Yorkshire. The role is a full time, permanent position offering a competitive salary plus pension and bonus.
Do you have a scientific background with a good working knowledge of pharmaceutical quality management systems and documentation?
Are you looking to further your career within a highly regarded pharmaceutical contract testing facility?
Broughton Laboratories Limited is an independent contract analytical laboratory based on the stunning Broughton Hall Business Park servicing the pharmaceutical and healthcare industries. We are an approved cGMP contract laboratory regularly inspected by both the MHRA and FDA. Reporting initially to the Quality Director, our Quality and Compliance Supervisor will be responsible for supporting quality, laboratory and stability operations across all functions; Pharma Services and Nicotine Containing Products (NCP).
What are the responsibilities of the Quality and Compliance Supervisor?
- To support quality activities within Broughton Laboratories in compliance with cGMP regulations.
- To perform quality/technical support to the operational teams using sound hypothesis and investigational judgment for the completion of out of specification, out of trend, non-conformance and deviation records.
- To perform quality/technical documentation review and approval of product and technique based analytical test methods following technical test method transfer.
- To perform quality/technical review and approval of test method development, test method assessment and test method validation protocols and reports in accordance with ICH Guidance.
- To support routine laboratory operations in delivering timely, accurate Quality Assurance results under strict cGMP regulations using LIMS.
- To plan and execute quality projects within Broughton Laboratories to support continuous improvement activities.
What skills do I need to have to become a Quality and Compliance Supervisor?
- Graduate of Chemistry or Analytical Chemistry related subject.
- Analytical experience of working in a commercial laboratory with working knowledge of various laboratory techniques such as; dissolution, titration, moisture analysis, related substances testing, HPLC, UV-Vis and FTIR spectroscopy.
- Experience of overseeing out-of-specification/out-of-trend investigations.
- Experience of performing risk assessment activities.
- Experience of reviewing and approving of technical documents; protocols, reports, technical summaries including the interpretation of analytical data (such as chromatograms and spectra) and conclusions.
- Understanding of statistics; such as %RSD, moving ranges, confidence intervals etc.
- Working knowledge of British, European and United States Pharmacopoeia.
- Experience of working with, and interpretation, of product specifications and client documentation.
- Good working knowledge of laboratory equipment including maintenance and qualification with emphasis on HPLC troubleshooting.
- Knowledge of data integrity with regards to MHRA/FDA expectations.
- Good knowledge of COSHH and health and safety.
- Excellent attention to detail for review and approval purposes.
- Good working knowledge of cGMP quality systems, preferably in a science based industry.
- An understanding of International Conference on Harmonisation Note for Guidance on Validation of Analytical Procedures, Validation of analytical procedures: Text and Methodology, ICH Topic Q2A and International Conference on Harmonisation Note for Guidance on Validation of Analytical Procedures, Validation of analytical procedures: Methodology, ICH Topic Q2B would be an advantage.
- Laboratory Information Management Systems (LIMS) knowledge would be advantageous.
Closing Date: 9th December 2016
Why not click ‘apply’ today? Don’t miss out on this opportunity to join a laboratory that the world’s leading pharmaceutical companies choose to work with as our Quality and Compliance Supervisor.
We are an equal opportunities employer. We aim to recruit staff on their suitability for the position advertised, without consideration of age, sex, marital status, disability, age or ethnic origin.