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QA Compliance and Operations Expert

2 weeks ago

Dublin, Dublin City, Ireland Cpl Resources - TEG Full time
Job Summary

Cpl Resources - TEG, in partnership with Pfizer, is seeking a QA Operations Specialist for an 11-month contract. The role is based onsite.

Pfizer's focus on quality ensures the delivery of safe and effective products to patients. Their quality culture is built on scientific principles and risk-based compliance, always prioritizing patient needs.

Main Responsibilities
  1. Review clinical and commercial drug batches for compliance with established specifications.
  2. Perform rigorous sampling and statistical process control procedures to identify deviations from standards.
  3. Approve investigations and change control activities to maintain compliance with configuration management policies.
  4. Participate in moderately complex projects, managing time effectively and developing short-term work plans.
  5. Independently assess Change Control activities for potential Quality and Operational Good Manufacturing Practices (cGMP) impacts.
  6. Investigate and document Quality Assurance deviations, escalating issues to the Quality Assurance Lead as needed.
  7. Maintain 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.
Qualifications
  1. 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
  2. Understanding of current Good Manufacturing Practices and relevant GxP regulations and standards
  3. Strong analytical and problem-solving skills
  4. Ability to work collaboratively within own team and across departments
  5. Proficiency in Microsoft Excel and Word
  6. Able to think critically and resolve problems proactively