Brief Description:

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.

Essential Functions

Key Responsibilities / Accountabilities

• 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
• Quality Vendor Management
• New Supplier/Vendor onboarding
• Internal and External Audit management

Detailed responsibilities / Accountabilities

• 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
• Management of quality qualifications and approval of vendor to ensure compliance to regulations.
• Ensures vendors are maintained and monitored using a risk-based approach which links into the external auditing process and the business.
• Lead and support internal and external audits, report write up and response management.
• 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

Required Knowledge, Skills, and Abilities

Skills:

• Working knowledge of office IT packages
• High level of written and verbal communication skills

Attributes and Behaviors:

• Motivated individuals that have extensive experience across many disciplines within the pharmaceutical industry and have spent a significant period of time within quality assurance, demonstrating the ability to develop quality systems.

Required / Preferred Education and Licenses

Education:

• 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