Essential Functions/Responsibilities

• Implement and oversee the quality systems ensuring compliance with all relevant regulatory guidelines and Jazz policies and strategies.
• Represent Quality during manufacturing operations and be available to resolve issues and provide guidance in a collaborative fashion.
• Provide quality and cGMP input and oversight of the manufacturing facility including data integrity.
• Generate QMS Standard Operating Procedures (SOPs) to reflect these processes, which are easy to follow and promote both compliance and efficient operations, in accordance with facility requirements.
• Review and approve procedures, documents and records (e.g. Specifications, Batch Records, Validation data, QC data, etc.) in accordance with the facility requirements.
• Review and approve technical support documentation. (Examples include cleaning, process, method validation).
• Generate and approve Quality documents (e.g. Annual Product Reviews, Licence variations etc.).
• Support the Deviation and OOS investigation systems, advising on assessing impact and approving final reports and associated CAPA.
• Support the site change control system, evaluating proposed change controls as assigned, making informed assessments of quality impact of changes.
• Support the facility Supplier Management program, including qualifications and re-qualifications of suppliers and materials, auditing vendors and providing oversight as required.
• Manage the QA responsibilities of external manufacturers of APIs, reviewing deviations and changes at the CMO site.
• Support site compliance program, performing internal audits, training internal auditors as required, and implementing audit action plans.
• Participate and follow-up in third party audits and/or inspections carried out at the site by the authorities or clients.
• Complete all required QMS assignments (CAPAs, investigations, actions etc) in accordance with agreed timelines.
• Perform production on the line AQLs, and the incoming inspection and disposition of raw materials, consumables, packaging.
• Assist in preparation and presentation of GMP training programmes.
• Participate in initiatives and action plans for the development of QA and improvement of GMP compliance.
• Involved in site-wide projects and continuous improvement processes.

Required Knowledge, Skills, and Abilities

• 3-7 years experience working in finished product pharmaceutical / biologics manufacturing, including analytical chemistry, quality assurance, quality control, development, and /or manufacturing areas.
• Excellent working knowledge of quality systems, FDA and EU regulations, cGMPs and ICH guidelines.
• Demonstrated capability in establishing collaborative working relationships at all levels, regardless of seniority.
• Possess fundamental scientific thought processes and demonstrated ability to apply this to overcome problems. An ability to think strategically and be a ‘go-to’ expert across the business in area of expertise.
• Recognize areas for improvement and use initiative to implement change programs in support of progress.
• Ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.
• Ability to deliver objectives on time, every time, while meeting all compliance and cost targets.
• Ability to generate documentation which is of a high standard.
• Possess good organizational skills and attention to detail.
• Possess good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally.
• Ability to handle and prioritize multiple assignments, changing priorities and meet deadlines.
• Demonstrated expertise in the area of Data Integrity highly desirable.
• Experience in participation in regulatory audits (HPRA or FDA) desirable.
• Computer skills i.e., Microsoft Office, Windows etc. Experience in Reliance, LIMS & SAP would be advantage.

Required/Preferred Education and Licenses

• BSc in science discipline required.
• Lead auditor certification highly desirable