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

Jazz Pharmaceuticals, Inc.; Sittingbourne; Hybrid; EUR 70,000 - 95,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Retirement Plan

Flexible Paid Vacation

Job summary

Jazz Pharmaceuticals, Inc. is seeking a Quality Compliance professional to support the Quality Compliance Manager in implementing the Quality Systems at the KSP facility and associated contractor sites.

Key duties include maintaining the QMS, handling CAPA, deviations, change control, and supplier/customer complaints, plus training and KPI reporting. The role involves coordinating with global process owners and contributing to QMR meetings.

Qualifications

• Bachelor's degree in science or related discipline (Master's preferred).
• Minimum 3 years' experience in pharma/biotech QA.
• Experience with GMP, GDP, and GACP where applicable.
• Experience in CAPA, deviations, change control and supplier/customer complaints.
• Strong documentation and written/verbal communication skills.

Responsibilities

• Maintain and improve the QMS to ensure compliance across sites.
• Lead CAPA, deviations, change control, and supplier/customer complaints.
• Perform root cause analysis and present findings in QMR meetings.
• Train staff on QMS processes and document control.

Skills

Quality systems

CAPA

GMP knowledge

Documentation control

Root cause analysis

Education

Bachelor's degree in science

Postgraduate qualifications (Master's or PhD) preferred

Tools

Quality Management System (QMS) software

Microsoft Office

Job description

**If you are a current Jazz employee please apply via the Internal Career site**Job Description**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 skillsJazz 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. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefitsJazz 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 for more information.