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

Jazz Pharmaceuticals Operations UK Limited; Tunstall; On-site; GBP 42,000 - 64,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Retirement plan

Paid vacation

Job summary

Jazz Pharmaceuticals Operations UK Limited is seeking a QA professional to assist the Quality Compliance Manager in implementing Quality Systems at the KSP facility and contractor sites.

You will manage CAPA, deviations, change control, and supplier/customer complaints, while contributing to QRM, RCA and staff training. This role supports QMS metrics and regulatory audits across sites.

Qualifications

• Bachelor’s degree in science or related discipline; postgraduate qualifications preferred.
• Minimum 3 years in pharma/biotech with GMP/GACP/GDP experience.
• Strong written and verbal communication skills; detail oriented and compliant.

Responsibilities

• Assist the Quality Compliance Manager and QA team in implementing the Quality Systems at the KSP facility and contractor sites.
• Manage CAPA, deviations, change control and supplier/customer complaints.
• Lead or participate in QRM and RCA activities and train staff in QMS processes.
• Collate QMS metrics, present data at QMR meetings and ensure regulatory and partner due diligence support.

Skills

Quality management

CAPA

GMP/GDP

Communication

QMS training

Education

Bachelor’s degree in science

Master’s degree or PhD preferred

Tools

Office IT packages

Job description

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. Please visit www.jazzpharmaceuticals.com for more information.

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

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.