LSC have a great contract opportunity for a Qualified Person to join a Limerick based Biotech Drug Substance Manufacturing Facility.
This is an exciting opportunity to work with next-gen manufacturing technologies, advanced data collection and analysis platforms that will result in safety and quality improvements, increased productivity, and variability reduction.
Note: This role requires you to be onsite at least 3 days per week.
The Role:
The Qualified Person will collaborate with various departments to support the technical agenda and serve as a technical mentor for the site quality assurance teams.
Minimum Requirements:
Must be approved by member state as a licensed QP to be named on the company license as a QP.
Minimum 6 years relevant experience
KEY RESPONSIBILITIES:
- QP Batch Certification: Certify and release biotech drug substance and drug product batches in compliance with GMP, Annex 16 and applicable regulatory authorisations.
- Final Quality Decision: Take accountability for the final decision on batch certification and release.
- Quality Leadership: Provide Quality leadership and technical oversight within the assigned area.
- GMP Documentation: Review and approve deviations, investigations, change controls, complaints, stability data and other critical GMP documentation.
- Validation & Compliance: Provide Quality oversight of qualification, validation and GMP compliance activities.
- Quality Monitoring: Ensure effective implementation of GMP systems through quality monitoring, audits and self-inspections.
- Regulatory Support: Issue QP declarations and support regulatory submissions, renewals and associated requirements.
Educational / Qualifications:
Required
* Must be approved by member state as a licensed QP to be named on the company
license as a QP.
* Level 7 qualification or higher in Science, Engineering or related discipline.
* Minimum 6 years relevant experience
Preferences:
* Strong understanding and working knowledge of cGMP, FDA, Data Integrity,
Quality Risk Management and other biopharmaceutical regulatory
For our contracting positions in Ireland's pharmaceutical industry, applicants must possess a Stamp 1G or a Stamp 4 visa.
We apologize for any inconvenience, as visa sponsorship is not available at this time. Thank you for your attention.
Apply via this advert or directly at Additionally please contact Siobhan Cummins at 021 7318904 if you have any more questions about this opportunity!
