The Senior QA Specialist is a key member of the team tasked with the successful day-to-day running of the Quality Operations and Quality Management System (QMS) for the facility as well as supporting other organizational objectives. The Senior QA Specialist will be responsible for operational and compliance support for manufacturing operations, maintain the site compliance program, and manage the supplier qualification program. The Senior QA Specialist will also represent quality on cross-functional and/or cross-company teams for business-critical development projects.
Essential Functions/Responsibilities
1. Represent Quality during manufacturing operations and be available to resolve issues and provide guidance in a collaborative fashion.
2. Represent and provide operational quality support for production, ensuring the manufacture of quality products in accordance with product licenses and filings.
3. Perform production on the line AQLs, and the incoming inspection and disposition of raw materials, consumables, packaging.
4. Review manufacturing-related documents (e.g. Specifications, Batch Records, Validation data, QC data, etc.) in accordance with the facility requirements.
5. Implement and oversee the quality systems (change controls, deviations, etc.) ensuring compliance with all relevant regulatory guidelines and Jazz policies and strategies.
6. Provide quality and cGMP input and oversight of the manufacturing facility including data integrity.
7. Manage and support the facility Supplier Management program, including qualifications and re-qualifications of suppliers and materials, auditing vendors, and providing oversight as required, ensuring all Quality Technical Agreements are managed and in compliance.
8. Generate Quality Systems metrics and prepare presentations suitable for Senior Management review.
9. Generate and approve Quality documents (e.g. Annual Product Reviews, License variations, etc.).
10. Support validation activities. Review and approve technical support documentation (Examples include cleaning, process, method validation).
11. Manage a QMS system to ensure compliance and adherence to the site metrics, including representing the site on the global QMS teams.
12. Manage the QA responsibilities of external manufacturers of APIs, reviewing deviations and changes at the CMO site.
13. Support site compliance program, performing internal audits, training internal auditors as required, and implementing audit action plans.
14. Participate and follow-up in third-party audits and/or inspections carried out at the site by the authorities or clients.
15. Partner with other Jazz SMEs to understand and proactively respond to changes in the regulatory environment and coordinate quality involvement as required.
16. Lead and support initiatives and action plans for the development of QA and improvement of GMP compliance.
17. Lead and support site-wide projects and continuous improvement processes.
Required Knowledge, Skills, and Abilities
1. 4 - 7 years’ experience working in finished product pharmaceutical/biologics manufacturing, including analytical chemistry, quality assurance, quality control, development, and/or manufacturing areas.
2. Excellent working knowledge of quality systems, FDA and EU regulations, cGMPs, and ICH guidelines.
3. Highly flexible, works well in a team environment, and has necessary skills to organize, communicate, influence, and lead.
4. Demonstrated capability in establishing collaborative working relationships at all levels, regardless of seniority.
5. 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.
6. Recognize areas for improvement and use initiative to implement change programs in support of progress.
7. Ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.
8. Ability to deliver objectives on time, every time, while meeting all compliance and cost targets.
9. Ability to generate documentation which is of a high standard.
10. Possess good organizational skills and attention to detail.
11. Ability to handle and prioritize multiple assignments, changing priorities, and meet deadlines.
Preferred Knowledge, Skills, and Abilities
1. Demonstrated expertise in the area of Data Integrity highly desirable.
2. Working experience in SAP and LIMS highly desirable.
3. Experience in participation in regulatory audits (HPRA or FDA) desirable.
Required/Preferred Education and Licenses
1. BSc in science discipline required.
2. Lead auditor certification highly desirable.
3. Qualified Person experience or educational requirements desirable.
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