QP (Qualified Person)
Job Type | Permanent |
Area | Sligo, Ireland |
Sector | QualityOperations & Manufacturing |
Start Date | |
Advertiser | Ashling Guthrie |
Job Ref | 3627 |
Job Views | 40 |
- Description
Team Horizon is seeking a QP for our Clients manufacturing facility in the West of Ireland. In this role you will be responsible for ensuring the compliance and quality of pharmaceutical products. This role requires expertise in quality assurance practices within an FDA and EMEA approved environment to maintain product safety and integrity.
As a QP for the site, you will work closely with our products throughout their manufacturing lifecycle, up until release from the site.
Why you should apply:
- This is an excellent opportunity to join a company who put their people & their patients first.
- You will have the resources and a global reach to empower your innovative mindset and make ground-breaking advancements happen.
- Make a lasting impact that's felt within healthcare and beyond.
What you will be doing:
- Ensure compliance with EudraLex Volume 4 EU Guidelines for Good Manufacturing Practice and Annex 16 requirements.
- Certify that each batch is manufactured and checked according to relevant laws, GMPs, and product specifications
- Oversee the disposition of bulk products, determining release or rejection based on manufacturing and testing data.
- Assess and resolve day-to-day quality issues, ensuring products meet quality and safety standards.
- Support cross-functional teams in process improvement and cost efficiency initiatives.
- Provide technical leadership and collaborate with stakeholders to enhance product quality and process optimization.
- Make informed decisions within quality systems, adhering to regulatory standards, and handle quality queries from the operations team.
- Promote a culture of excellence in quality and compliance throughout the organization.
- Participate in internal and external audits, ensuring readiness and compliance with quality standards.
What you need to apply:
- Bachelor's degree in a science discipline and a minimum of 5 years of experience in the pharmaceutical industry.
- MSc in Industrial Pharmaceutical Science or equivalent recognized for QP status under Directive 2001/83/EC, Article 49.
- Experience as a QP on a license preferrable
- Experience in aseptic processing and quality functions.