QP – Clonmel

The Operational Quality Manager/QP will act in accordance with Annex 16, EudraLex, Volume 4 and directive 2001/83/EC to support disposition of  products. The Operational Quality Manager/QP plays a key role on site and will sit on the Quality Leadership Team. 

Role:

• Manages the batch disposition process to ensure timely release of products.
• Ensures the batch disposition process maintains compliance with site practices & regulatory requirements.
• Disposition of  products and materials in accordance with directive 2001/83/EC and Annex 16, EudraLex, Volume 4, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use.
• Support major investigations, ensuring all product deviations are closed prior to batch release.
• Reviews and approves Product Quality Reviews.
• Reviews and approves new and revised master manufacturing records.
• Participates in cross-functional teams as Quality/Qualified Person representative.
• Participate in third party/supplier audits, as required.
• Review annual customer complaints.
• Participation in any product recall or product defects.
• Actively contribute to continuous improvement initiatives.
• Conduct duties in a safe manner and report all safety issues and concerns.
• Complete all duties as per relevant SOP’s.
• Review of investigation reports.
• Review of validation protocols.
• Review of Quality Documentation as appropriate e.g. Bill of Materials etc.
• Work with relevant departments to ensure timely closure of Quality Actions / Findings.
• Provide additional QP support to quality related issues, as required

Skills:

• Must meet the minimum training/education requirements for QP qualification
• Must have at least 5-7 years’ experience working within a Quality Assurance role
• Work experience acting as Qualified Person, named on a Manufacturing and Importation Authorisation (MIA) is highly desirable. 
• Finished dosage formulation manufacturing experience is a requirement for the role
• Outstanding organisational and time-management skills.
• Ability to leverage/collaborate effectively with internal and external stakeholders
• Excellent written and verbal communication and interpersonal skills.
• Strong problem-solver.
• Resourceful.
• Independent, critical thinker with strong decision-making skills.
• Comfortable working in a busy, fast paced regulated manufacturing environment.