We are partnering with a leading pharma organization in Tipperary, who are looking to hire a Qualified Person.
In this role, you will review and approve product quality before it's released into the market, and manage the batch disposition process.
Overview of Main Responsibilities (full job description available on request):
- Ensures the batch disposition process maintains compliance with site practices & regulatory requirements.
- Support major investigations, ensuring all product deviations are closed prior to batch release.
- Reviews and approves Product Quality Reviews.
- Participate in third party/supplier audits, as required.
- Review annual customer complaints.
- Review of validation protocols.
- Conduct duties in a safe manner and report all safety issues and concerns.
- 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 Qualified Person looks like:
- Must meet the minimum education requirements for QP qualification.
- Must have at least 4+ 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.
- Excellent written and verbal communication and interpersonal skills.
- Comfortable working in a busy, fast-paced regulated manufacturing environment.
For a confidential discussion and more information on the role, please contact Alicja Burchardt.