Senior Quality Assurance Analyst

If you are a current Jazz employee please apply via the Internal Career site

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.

Job Description

Job title: Senior Quality Assurance Specialist

Location: On site, Villa Guardia, Como

Brief Description:

Active contribution to maintenance and improvement of the Quality System at the Manufacturing site and overview of the CMO activities for Drug Product

Essential Functions/Responsibilities

• Independently conducts proper investigations in case of deviations and appoints the required personnel for an effective root-cause analysis and proper definition of suitable corrective/preventive actions.

• Defines and verifies Corrective / Preventive Actions following investigations.

• Check consistency and application of the Company Quality System (eg. SOPs application, Quality Agreements) by both GMP related relevant departments and external personnel.

• Makes sure that complaints from customers and to suppliers are recorded and managed according to Company’s SOP and identifies and collaborates with required personnel for an effective root-cause analysis and proper definition of suitable corrective/preventive actions.

• Coordinate internal department at site for management of change and deviation investigations

• Supervises the CMO regarding manufacturing, change, deviations and release activities of the Drug Product.

• Writes and reviews SOPs, technical reports and other GMP documents in compliance with the applicable standards.

• Performs a complete review of the batch production records verifying its accuracy, completeness, and presence of relevant attachments in compliance with what prescribed by the relevant SOPs.

• Before the manufacturing of a new batch, issues the related batch record and packaging batch record according to what prescribed by relevant SOP.

• Guarantees traceability and proper management of the relevant document of the quality system with specific reference to: Batch Records, CoAs, Training Records, Failure/change control records, and other relevant GMP documents.

• Evaluates changes for his / her area of competence and performs relevant actions for the change implementation.

• Organizes and conduct self-inspections to affected departments, supports during audit/inspection from clients/Regulatory Authorities.

• Performs periodic review in production (QAIP) according to relevant SOP.

• Writes, review or approves the Product Quality Review documents.

• Provide and organize training for both internal and external personnel according to what prescribed by relevant procedures.

• Collaborates in the supervision of the rules and registrations related to the use of narcotic substances on the site.

• Embrace the Continuous Impr