Quality Compliance

2 weeks ago

Cork, Cork, Ireland CPL Full time
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:

- Implementing, monitoring, maintaining, and improving the systems and processes used for Quality compliance.
- Maintenance and administration of training systems and processes.
- Roll out of global initiatives.
- Supporting departmental colleagues and partnering lines with guidance on documentation, compliance issues and systems support.
- Working proactively to ensure delivery of on-time high quality records, investigations, and associated actions.
- Monitoring metrics and trends to improve compliance standards that will meet internal and external auditor expectations.
- Lead and support quality-based investigations and associated action outcomes, including on time completion.
- 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.
- 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).
- Lead compliance inspections and audits, metric generation, and trending of data.
- Development and administration of training within the facility.
- Oversee compliance with Data integrity and ALCOA principles.
- Maintain regulatory compliance in accordance with current Good Manufacturing Practices and Pfizer quality standards.
- Oversight and support of documentation practices associated with equipment validation and commissioning, SOP management and training.
- Assist departmental colleagues with technical help and guidance on IT compliance and documentation systems.
- Provide quality oversight of GMP service providers, where reqruied.

Basic Qualifications

- University graduate in a science related subject (Chemistry/ Biochemistry or equivalent preferred) with 2 years of relevant experience.

Qualifications/Skills, Knowledge & Experience

- Good attention to detail and good documentation practices.
- Knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards (highly desirable).
- Experience in quality management systems.
- Experience in training management systems.
- Competent in Microsoft Office programs, Word, Excel, PowerPoint etc.

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