Role Title: Quality Compliance & Training Specialist
Location: Pfizer RCMF Facility, Cork. IRL
Duration : 11 month Contract
Role Summary
The Quality Compliance & Training Specialist will work within the Pfizer Ringaskiddy Clinical Manufacturing Facility (RCMF) as part of a small team responsible for Good Manufacturing Practice (GMP) quality compliance and training activities, within our small molecule Active Pharmaceutical Ingredient (API) clinical manufacturing facility. The successful candidate will be a member of a small, dynamic, highly competent, and engaged team of colleagues responsible for delivering excellent performance across the fundamentals of safety, quality, supply and cost. RCMF is part of the Pfizer Research & Development (PRD) organisation but is co-located with Pfizer Global Supply (PGS) on the Ringaskiddy site. Cross site and cross company liaison will be a key part of the function, including roll out of global initiatives within RCMF. As a Quality Compliance and Training Specialist, the successful candidate will be responsible for:
1. Implementing, monitoring, maintaining, and improving the systems and processes used for Quality compliance.
2. Maintenance and administration of training systems and processes.
3. Roll out of global initiatives.
4. Supporting departmental colleagues and partnering lines with guidance on documentation, compliance issues and systems support.
5. Working proactively to ensure delivery of on-time high quality records, investigations, and associated actions.
6. Monitoring metrics and trends to improve compliance standards that will meet internal and external auditor expectations.
7. Lead and support quality-based investigations and associated action outcomes, including on time completion.
8. Provide Quality review and oversight of documentation associated with change requests, manufacturing, and cleaning to ensure compliance with global regulatory agencies and Pfizer quality standards.
9. Lead the development and continuous improvement of systems that will maintain or enhance compliance within the department (e.g., documentation life cycle, training practices, SOP improvements, process flows).
10. Lead compliance inspections and audits, metric generation, and trending of data.
11. Development and administration of training within the facility.
12. Oversee compliance with Data integrity and ALCOA principles.
13. Maintain regulatory compliance in accordance with current Good Manufacturing Practices and Pfizer quality standards.
14. Oversight and support of documentation practices associated with equipment validation and commissioning, SOP management and training.
15. Assist departmental colleagues with technical help and guidance on IT compliance and documentation systems.
16. Provide quality oversight of GMP service providers, where reqruied.
Basic Qualifications
17. University graduate in a science related subject (Chemistry/ Biochemistry or equivalent preferred) with 2 years of relevant experience.
Qualifications/Skills, Knowledge & Experience
18. Good attention to detail and good documentation practices.
19. Knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards (highly desirable).
20. Experience in quality management systems.
21. Experience in training management systems.
22. Competent in Microsoft Office programs, Word, Excel, PowerPoint etc.