Qualified Person - Dublin West

Requirements

• interpersonal
• including excellent written
• Must have excellent communication skills
• Detailed experience of Quality Assurance of aseptic medicinal products and in particular biopharmaceuticals.
• Eligible and demonstrated ability to act as Qualified Person within EC/EEA.
• Minimum 5 years GMP related experience in biopharmaceutical / pharmaceuticals.
• collaboration
• and negotiation skills
• with a team oriented approach.
• Extensive demonstrated pharmaceutical quality experience.
• Must have a minimum of 1 years’ experience acting as a Qualified Person
• Bachelor’s degree required; preference given to candidates with advanced degrees
• and control under tight deadlines.
• schedule
• Must have strong task management skills with the ability to prioritize
• Must have demonstrated understanding of the processes and interactions essential for ensuring and maintaining regulatory compliance.
• and distribution processes and associated global regulatory GMP/GDP requirements.
• testing
• packaging
• Must have thorough knowledge of biopharmaceutical / pharmaceutical manufacturing
• Eight or more years of cGMP experience preferred; consideration will be given to other relevant experience and education.