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

Jazz Pharmaceuticals; Dublin; On-site; GBP 55,000 - 90,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Retirement savings plan

Flexible paid vacation

Job summary

Jazz Pharmaceuticals supports the QA team at the KSP facility with quality systems implementation and QMS maintenance. The role includes coordinating with global process owners, leading RCA, and ensuring documentation and training meet regulatory expectations.

The candidate should hold a science degree, have at least 3 years in pharma quality environments (GMP/GACP/GDP), and possess strong IT and communication skills. Benefits are included.

Qualifications

• Bachelor’s degree in science or related discipline is required.
• Masters/PhD considered a plus for advanced roles.
• Experience in GMP/GACP/GDP quality environments.

Responsibilities

• Assist Quality Compliance Manager and QA team with QMS implementation at KSP facility and contractor sites.
• Manage and maintain the quality management system (QMS).
• Lead root cause analysis (RCA) and drive corrective actions.
• Liaise with global process owners to align QMS across sites.
• Provide QMS training and collate KPI data.
• Present QMS data at QMR meetings.
• Prepare, review, and update QMS processes.
• Ensure training records are up to date.
• Escalate and manage quality events and complaints within guidelines.
• Assist in creating technical and supplier quality documents.

Skills

Office IT packages

Written and verbal communication

Education

Bachelor’s degree in science or related discipline

Master’s or PhD preferred

Job description

Jazz Pharmaceuticalsis 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 inDublin, Irelandwith research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.comfor more information.

Job Description

About theRole:

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:

• 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. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits