This position is part of the PDQA team within the Manufacturing Quality team at Jazz Pharmaceuticals. The position supports the Product Development (PD) manufacturing operations team and development of Investigational Medicinal Products (IMPs) and ensures that suitable IMP is provided to the Clinical Trials Supply Management (CTSM) Team for use in clinical trials.
Essential Functions/Responsibilities
The individual is responsible for but not limited to:
* Represent PDQA on CMC matrix teams for Jazz development Projects.
* Monitor the GMP operations at the Contract Manufacturer/Packager of IMPs to ensure that all operations are fully in compliance with current international standards for cGMP.
* Perform batch review and disposition, review product complaints, change controls and product related investigations (OOS investigations, deviations and CAPAs).
* Generation of Product Specification Files or Technical Review Files.
* Act as a Qualified Person (QP) named on Jazz Pharmaceuticals Manufacturing and Import Authorization (MIA) for Investigational Medicinal Products to ensure clinical trial supply
* Collaboration with contract manufacturers, packagers and testing laboratories to resolve any quality issues.
* Act as lead auditor in third party vendor audits for IMPs, to include: GMP contract manufacturing, analytical testing and storage facilities when required to ensure compliance with Jazz requirements and country specific regulations.
* Oversight of the product stability program for IMPs, including stability data review.
* Develop and write SOPs & controlled documents as required.
* Review and approval of IMP product labelling.
* Build authentic relationships and participate in meetings, as required, with contract manufacturers and maintain all product-related, Quality Technical Agreements (QTA’s).
* Operating supplier management process to include qualification and discontinuation of contractors.
* Participate in continuous improvement projects utilizing Operational Excellence programs.
* Developing and maintaining Quality Systems and ensuring that all operations are fully in compliance with current international standards for cGMP.
* Support validation activities.
* Support CTSM with on time Quality review and approvals to ensure timely supply of clinical material to trial sites.
* Work directly with other key Jazz Pharmaceutical departments to ensure compliance and productive working relationships.
* Work closely with other members of Technical Operations organization to ensure delivery of key project objectives and timelines.
* Supporting regulatory submissions.
Required Knowledge, Skills, and Abilities
* Experience working in finished product pharmaceuticals, including analytical chemistry, quality assurance, quality control, development, and /or manufacturing areas.
* Experience with third party vendor auditing, complaint handling and change control.
* Thorough understanding of quality systems and GMP/GDP.
* Very good oral and written communication skills.
* Interpersonal skills and professional skills to interact at all levels including senior executives, contractors, and colleagues.
* Experience working with contract manufacturing.
* Experience interfacing with regulatory bodies or supporting regulatory submissions.
Required/Preferred Education and Licenses
* Bachelor's degree in chemistry, biology or a related discipline.
* Eligibility to act as a licensed Qualified Person.
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