Collaborating with Pfizer and Cpl, we seek a QA Operations Specialist for an 11-month fixed-term contract at the Grange Castle site in Dublin.
About Us
Pfizer's commitment to quality ensures the delivery of safe and effective products to patients every day. Our science and risk-based compliant quality culture is flexible and innovative, always prioritizing patient needs.
Your Role
* 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.
Requirements
* High school diploma (or equivalent) with 8+ years of experience or associates 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.
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.