QA Validator

2 weeks ago

Limerick, Limerick, Ireland beBee Careers Full time

Quality Assurance and Compliance Specialist

This role requires a Quality Assurance and Compliance Specialist to oversee the Validation department's adherence to regulatory requirements. The successful candidate will ensure that processes are in place to guarantee compliance and support the implementation of company manufacturing standards policies and procedures.

The day-to-day responsibilities of this position include:

  • Maintaining the Validation department's compliance tracker for quality records and engaging with the team on a frequent basis to discuss the status of their records, including Notice of Event (NOE), Change Controls (CC), and Corrective Action Preventative Actions (CAPA).
  • Supporting reporting and driving closure of quality records.
  • Mentoring quality record owners and conducting compliance reviews where necessary to ensure that quality records are submitted right first time.
  • Coordinating the reconciliation and return of documents, such as protocols, forms, and logbooks, to the document control department in a timely manner.
  • Supporting the Audit Ready 365 program and working with teams to plan, coordinate, and track mentor sessions.
  • Supporting internal and regulatory audits by coordinating requests for the QA Validation team.
  • Driving quality and compliance in Validation activities by aligning practices related to compliance, audit readiness, and training for IOPS QA Validation.
  • Collaborating to identify improvements across both sites.
  • Developing and deploying validation-specific training.
  • Influencing the development and revision of local and global policies, procedures, and business processes in alignment with industry standards and best practices for validation.

To be considered for this position, candidates must have a BS/BA in Engineering, Chemistry, or Life Sciences and at least 3 years of experience. Experience within validation or quality compliance is beneficial.

We offer a comprehensive benefits package that includes health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.

Regeneron is an equal opportunity employer and welcomes applications from qualified individuals without regard to race, color, religion or belief, sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic.

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