Senior Quality Assurance Professional

1 day ago

Cork, Cork, Ireland beBeeQuality Full time €60,000 - €80,000
Job Title

Senior Quality Assurance Specialist

Job Description

We are seeking a Senior Quality Assurance Specialist to join our team. This role will be responsible for driving quality assurance activities in alignment with cGMP principles and regulatory expectations from agencies such as the FDA and EMEA.

The successful candidate will own compliance within assigned areas and collaborate with cross-functional teams to uphold high standards of quality and regulatory adherence.

Key Responsibilities
  • Lead the QA review and approval process for Change Controls, Deviations/CAPAs, SOPs, and related documentation, ensuring full compliance with GMP and site-specific requirements.
  • Manage QA operational duties related to product disposition, ensuring timely and compliant decision-making.
  • Monitor and evaluate new regulatory guidance and industry best practices, assessing their impact on quality systems and driving necessary updates.
  • Assist in developing and maintaining QA policies, SOPs, and reports that support site operations and compliance.
  • Champion continuous improvement initiatives by identifying opportunities to enhance quality processes and operational efficiencies.
  • Participate in risk management activities, applying relevant guidance and industry best practices to mitigate potential quality risks.
  • Support and execute the internal audit program, including conducting audits as required to ensure ongoing compliance and improvement.
Required Skills and Qualifications
  • Degree in Science, Quality, or a related Technical field.
  • 5-10 years of experience in Quality Assurance, Quality Control, or Technical Operations within FDA/EMEA regulated environments.
  • Strong written and verbal communication skills, capable of clearly articulating complex quality issues.
  • Logical thinker with the ability to remain proactive and composed under pressure.
  • Proven ability to work effectively both independently and collaboratively within a team.
  • Exceptional attention to detail and precision in preparing and reviewing GMP documentation.
  • Hands-on experience with quality management systems such as Veeva, SAP, PAS-X, or similar platforms.
Benefits

This is a mid-senior level contract role in the pharmaceutical manufacturing industry.

Others

Please submit your application to be considered for this opportunity.

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