QA Compliance Specialist

7 days ago

Bray, Wicklow, Ireland beBeeQuality Full time €67,892 - €89,347
Job Title: Quality Assurance Professional

We are seeking a highly skilled and experienced Quality Assurance Specialist to join our team.

Job Description:

As a Quality Assurance Specialist at Zoetis, you will play a crucial role in ensuring the site is permanently inspection ready and that processes for manufacturing Active Pharmaceutical Ingredients are in compliance with cGMP and regulatory requirements.

Your key objectives will include providing quality oversight and support for operations, including manufacturing, testing, packaging, and material management across all phases of development and commercial manufacture.

Key Responsibilities:

  • Ensure GMP activities are in compliance with regulatory, corporate, and site procedures
  • Provide on-the-spot support and guidance for GMP product quality assurance and compliance in Manufacturing Operations, Laboratory Operations, and Warehousing activities
  • Review and approve Batch Records, Cleaning Records, Master Batch Records, and other critical documents
  • Quality review of SOPs, EOPs, Change Requests, Protocols, Reports, etc.
  • Support Quality Business Partner for PPQ, CPV, and APR activities, partnering with GMT, Laboratories, Operations, and Regulatory to ensure successful transfer and validation of processes

Requirements:

  • Undergraduate degree in pharmaceutical, biological, or chemical sciences
  • Relevant advanced degree preferred
  • 5+ years' relevant experience in Pharmaceutical and/or Animal Health industry, with current knowledge of cGMP's and regulatory guidance
  • Significant experience in Equipment Commissioning/Qualification, Cleaning Validation, and Process Validation is desirable

Technical Skills and Competencies:

  • Demonstrated knowledge and success in working with cross-functional teams
  • Ability to develop and adhere to self-directed standard work- organized and methodical with ability to take initiative with minimal guidance
  • Strong written and oral communication skills and ability to collaborate effectively with others

Physical Position Requirements:

  • Site-based position in Rathdrum, Ireland
  • Travel may be required as part of the role, up to 10% of the time

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