Job Description:

This position is part of the PDQA group with the Drug Discovery and Pharmaceutical Development Quality team at Jazz Pharmaceuticals. The position supports the Pharmaceutical Development and Manufacturing Sciences Team (PDMS) in contract manufacturing operations 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.

Responsibilities:

The individual is responsible for but not limited to:

• Represent PDQA on CMC matrix teams for Jazz development Projects

• Monitor the operations at the Contract Manufacturer of IMPs, perform batch review, review product complaints, deviations, change controls and product related investigations (OOS investigations, deviations and CAPAs).

• 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.

• Managing the product stability programme for IMPs

• Develop and write SOPs & controlled documents as required.

• Generate and maintain Product Specification Files (PSFs)

• Review and approval of product labelling

• Build authentic relationships and participate in meetings, as required, with suppliers and contract manufacturers and maintain all product-related, Quality Technical Agreements (QTA’s), QP Agreements and QP Declarations.

• Operating supplier management process to include qualification, re-qualification and discontinuation of contractors.

• Participate in continuous improvement projects utilising 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.

• Supporting CTSM with on time Quality review and approvals to ensure timely supply of clinical material to trial sites.

Other Responsibilities:

• 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

• Contribute to management of the supplier approval program through audit participation and GxP compliance oversight

• Assist with troubleshooting quality issues at Partner’s or vendor’s site or associated with technology transfer, when required.

• Maintain appropriate Quality Technical Agreements with all GxP vendors

• Supporting regulatory submissions

Personal Competencies:

• Bachelor's degree in chemistry, biology or a related discipline

• Experience working in finished product pharmaceutical/ biologics, 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