Cpl in partnership with our client Pfizer are seeking a QA Operations Specialist to join the team for an 11 month fixed term contract at their state of the art site in Dublin, Grange Castle. This is an onsite role.
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
- 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
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