Job description
Role Summary
The RCMF facility is currently undergoing construction on the Ringaskiddy API site and will be a multi-product clinical API manufacturing facility enabled for continuous processing using our FAST platforms. The design is focused on combining existing capabilities from our clinical workflows with the very best advances in technology and architecture to build a truly contemporary API clinical facility which will support the needs of our new products small molecule portfolio into the future. The RCMF will scale up new clinical products developed in our CRD laboratories at our research sites in the U.S. (Groton, Connecticut) and in the UK (Sandwich, Kent) and will tech transfer successful new products from the RCMF to our commercial manufacturing site in Ringaskiddy.
The Quality Compliance and Training Specialist will work within the RCMF team to lead the coordination and completion of Good Manufacturing Practice (GMP)/Quality compliance) activities for the Active Pharmaceutical Ingredient (API) manufacturing area aligned with new product introduction workflows utilising cutting edge continuous manufacturing technologies. You will be a member of a dynamic, highly competent, engaged team of colleagues responsible for delivering a fully operational facility with excellent performance across the fundamentals of safety, quality, supply and cost. CRD is a global department and while work will be based at the RCMF, interaction with other sites will be necessary.
This position is an individual contributor role that has the potential for future management of people.
As the 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
- Set-up, maintenance and administration of training systems and processes
- 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
- Maintain the CRDM Active Library with oversight to ensure that all documentation is accurate, complete, available, and controlled
- 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
- 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
- Proved input to PQS reviews and CAS reports execution
BASIC QUALIFICATIONS
- University graduate in science related subject (Chemistry/ Biochemistry or equivalent preferred) with 3 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 administered systems
- Experience in training systems
- Competent in Microsoft Office programs, Word, Excel, PowerPoint etc.
Work Location Assignment: Flexible
Additional Information
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In order to be considered for this position in Ireland you need to be legally eligible to work in Ireland.
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Please note there is no relocation support available for this position
How to apply
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Make a difference today, all suitable candidates should apply with CV below. We are looking forward to hearing from you!
Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
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