QA Operations Specialist

QA Operations Specialist page is loaded## QA Operations Specialistlocations: Ireland - Dublin - Grange Castletime type: Full timeposted on: Posted Todayjob requisition id: 4941178**Use Your Power for Purpose**Every day, Pfizer's unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients.**What You Will Achieve**In this role, you will:* Evaluate and review clinical and commercial drug batches to ensure compliance with established specifications.* Conduct rigorous sampling and statistical process control procedures to identify deviations from standards.* Approve investigations and change control activities to maintain compliance with configuration management policies.* Contribute to moderately complex projects, managing time effectively and developing short-term work plans.* Independently assess Change Control activities for potential Quality and Operational Good Manufacturing Practices (cGMP) impacts.* Investigate and document Quality Assurance deviations, escalating issues to the Quality Assurance Lead as needed.* Ensure regulatory compliance with current Good Manufacturing Practices (GxP) and provide Quality Review and oversight of site documentation to meet global regulatory and Pfizer quality standards.**Here Is What You Need** (Minimum Requirements)* High school diploma (or equivalent) with 8+ years of experience or associate's degree with 6+ years of experience or BA/BS with 2+ years of experience or MBA/MS with any years of relevant experience* Solid understanding of current Good Manufacturing Practices and relevant GxP regulations and standards* Strong critical thinking skills* Ability to work effectively within own team and interdepartmental teams* Good working knowledge of Microsoft Excel and Word* Proactive approach to problem-solving**Bonus Points If You Have** (Preferred Requirements)* Experience in quality administered systems* Strong organizational skills and attention to detail* Experience with regulatory compliance and documentation* Ability to mentor and review the work of other colleagues Work Location Assignment: On Premise **Additional Information*** In order to be considered for this position in Ireland you need to be legally eligible to work in Ireland.* Please note there is no relocation support available for this position**How to apply*** Make a difference today, all suitable candidates should apply with CV below. We are looking forward to hearing from youPurpose**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 StrategyOne 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 OpportunityWe 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. Disability InclusionOur mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts hereQuality Assurance and ControlPfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We're looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.
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