Senior Associate Quality Assurance Specialist (12 Month Fixed Term Contract)

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