Quality Assurance Specialist

1 week ago

Cork, Cork, Ireland beBeeQuality Full time €90,000 - €120,000

Overview:

">Quality Assurance Specialist - API External Manufacturing">

We are seeking a skilled Quality Assurance Specialist to join our team in ensuring the quality of our API external manufacturing processes.

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Main Responsibilities:

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  • ">
  • Provide quality oversight of Contract Manufacturing Organizations (CMs) and ensure compliance with cGMPs and regulatory commitments.">
  • Serve as a liaison between CMs and our organization, providing initial point of contact for all quality-related issues.">
  • Evaluate and disposition API batches, ensuring that documented checks have been completed for Certificates of Testing and Certificates of Environmental Monitoring.">
  • Assess the impact of deviation investigations and changes, ensuring that all appropriate records are documented and retrievable.">
  • Maintain awareness of external regulatory agency findings and review/approve documents related to quality control activities.">
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Requirements:

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Bachelor's Degree in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences is required.

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Five plus years of GMP manufacturing knowledge and/or experience in API or finished product manufacturing, QA is required.

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Demonstrated coaching and mentoring skills, thorough technical understanding of quality systems and regulatory requirements, and excellent interpersonal skills are preferred.

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We offer a dynamic work environment, competitive compensation package, and opportunities for professional growth and development.

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At our organization, we are committed to helping individuals with disabilities to actively engage in the workforce and ensure equal opportunities when vying for positions.

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If you require accommodation to submit a resume for a position at our organization, please complete the accommodation request form for further assistance.

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We do not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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We value diversity and inclusion in the workplace and welcome applications from qualified candidates from diverse backgrounds.

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Please note that this email address is intended for use only to request an accommodation as part of the application process.

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Languages: English

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Job Type: Full-time

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Language: en

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