Operational Quality Manager/QP | Tipperary
The Operational Quality Manager/QP plays a key role on site and will sit on the Quality Leadership Team.
Overview of Main Responsibilities (full job description available on request):
- 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 company 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 a Quality/Qualified Person representative.
- Participate in third-party/supplier audits, as required.
- 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.
- 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
What the ideal candidate looks like:
- Must meet the minimum training/education requirements for QP qualification.
- Must have at least 5-7 years of experience working within a Quality Assurance role.
- Work experience acting as a 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.
What you will get in return:
- Competitive Salary (depending on experience).
For a confidential discussion and more information on the role, please contact Aisling Lane.