Laboratory jobs in Kent

About the Role:

To assist the Quality Compliance Manager and other QA team members in the implementation of the Quality Systems at the KSP facility and associated contractor sites.

Key Responsibilities:

• Managing and maintaining of the quality management system:

  • Corrective and preventative actions (CAPA)

  • Deviations

  • Change control

  • Supplier and customer complaints

  • Quality risk management (QRM)

• Leading root cause analysis (RCA)

• Liaising with global process owners to ensure consistency in the QMS between sites and functions

• Training in the QMS

• Collating QMS metrics and KPI data

• Presenting QMS data at quality management review (QMR) meetings

Detailed Responsibilities:

• Prepares, reviews, updates and completes QMS processes

• Ensures training records are kept up to date

• Carries out their work in a way that will not adversely affect their own, or others’ health, safety and security or the environment and reports any shortcomings in GW arrangements

• Ensure all complaints are documented, investigated and closed out within agreed guidelines. That issues are escalated as required

• Strives to ensure quality events are closed within agreed timeframes and facilitates management of quality events across KSP

• Assisting in the assembly of the product quality review

• Ensuring that regulatory, marketing partners due diligence and other audit/inspections performed at GW are supported with efficient document retrieval and supply of the technical information

• Assist in the creation of technical agreements, supplier agreements and quality risk assessments

• Participate or leads projects to deliver improvements in productivity and efficiency in all areas relevant to complaints

• Authors and reviews all required quality documents

• Creates training packages for QMS process at KSP

• Authors and edits SOPs associated with the QMS at KSP

Essential Skills:

Knowledge:

• Typically, Bachelor’s degree in science or related discipline

• Post-graduate qualifications (Master’s, PhD) preferred

Experience:

• Minimum 3 years relevant work experience in the Pharmaceutical, Biotechnology or a related industry

• Experience working within a quality environment, including experience in GMP, GACP and GDP

Skills:

• Working knowledge of office IT packages

• High level of written and verbal communication skills