Senior Associate QA Specialist - 12 Month FTC in Sittingbourne

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide.

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

• 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 (or equivalent) in science or related discipline, Post-graduate qualifications (Master’s, PhD) preferred
• Experience: Extensive work experience in the Pharmaceutical, Biotechnology or a related industry, Experience working within a quality environment, including experience in GMP, GACP and GDP

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation.