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
o Corrective and preventative actions (CAPA)
o Deviations
o Change control
o Supplier and customer complaints
o 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
* 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 / Preferred Qualifications
* Working knowledge of office IT packages
* High level of written and verbal communication skills
* 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
* Bachelor's degree (or equivalent) in science or related discipline (typical)
* Post‑graduate qualifications (Master's, PhD) preferred
* Extensive work experience in the Pharmaceutical, Biotechnology or a related industry
* Experience working within a quality environment, including experience in GMP, GACP and GDP
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