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Medical Regulatory Compliance Specialist

2 weeks ago

Dublin, Dublin City, Ireland West Pharmaceutical Services, Inc Full time
About the Role

We are seeking a highly skilled Qualified Person (QP) to join our team at West Pharmaceutical Services, Inc. The successful candidate will be responsible for ensuring the quality and compliance of our medicinal products, in accordance with EU GMP regulations.

The QP will work closely with our quality assurance team to ensure that all aspects of the quality management system are met, including batch certification, release decisions, and regulatory compliance. This is an exciting opportunity for a motivated and experienced professional to join our team and contribute to the success of our company.

Key Responsibilities

• Ensure compliance with EU GMP regulations and guidelines
• Review and approve batch records and documentation
• Conduct risk assessments and investigate deviations
• Collaborate with cross-functional teams to resolve quality issues
• Develop and implement process improvements to enhance quality and efficiency

Requirements

• Bachelor's degree in a relevant field (e.g., pharmacy, chemistry, biology)
• Postgraduate qualification in pharmaceutical manufacturing technology or equivalent experience
• Minimum 5 years' experience in quality assurance or regulatory affairs
• Strong knowledge of EU GMP regulations and guidelines
• Excellent communication and problem-solving skills

What We Offer

• Competitive salary and benefits package
• Opportunities for professional growth and development
• Collaborative and dynamic work environment
• Recognition and rewards for outstanding performance

This is an excellent opportunity for a qualified and motivated individual to join our team and contribute to the success of our company. If you are passionate about quality and regulatory compliance, we encourage you to apply.