Job Title: Senior QA Compliance Specialist
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About the Role:
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We are seeking a highly skilled and experienced Senior QA Compliance Specialist to join our team. As a key member of our Quality Assurance department, you will play a critical role in ensuring the highest standards of quality and compliance across all aspects of our business.
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Responsibilities:
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* Support the qualification of new material suppliers and GMP service providers
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* Participate in auditing of GMP suppliers and GMP service providers
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* Act as SAP Key User for material supplier data
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* Support the review and approval of GMP supplier and service provider changes
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* Support the resolution of quality deviations and closure of CAPAs
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* Support the internal audit program
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* Participate and follow-up on audits and/or inspections carried out at the site by Regulatory Authorities or Clients
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* Manage and provide support for the site electronic quality management system (EQMS)
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* Provide site metrics and KPIs as required for the Quality Management System (QMS)
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* Provide support for the Quality Management Review (QMR) as applicable
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* Review and Approve Risk Assessments, change controls, deviations and complaint investigations
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Requirements:
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* Bachelor's degree in a technical discipline (e.g. biochemistry, chemistry, engineering)
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* Demonstrated knowledge of Quality Management System and continuous/process improvement tools
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* At least 3-5 years' experience in the biotechnology and/or pharmaceutical industry within a Quality role
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* Strong technical aptitude and knowledge of cGxP requirements and regulations
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* Able to read & comprehend technical documentation & execute procedures
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* An Auditor qualification would be an advantage
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Benefits:
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* Pension
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* VHI
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* Bonus
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* Parking
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Company Culture:
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Our company is committed to providing a supportive and inclusive work environment where employees can thrive and reach their full potential. We value diversity, equity, and inclusion and are dedicated to creating a workplace that reflects these values.
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What We Offer:
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In addition to a competitive salary and benefits package, we offer a range of perks and incentives to support your career growth and well-being. These include opportunities for professional development, flexible working arrangements, and a comprehensive employee assistance program.
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