Experienced Qualified Person - QP
Certify and release batches of pharmaceutical products in compliance with EU GMP Annex 16, EU Directives 2001/83/EC and 2001/20/EC, and HPRA requirements. Ensure alignment with product Marketing Authorizations (MA).
Main Responsibilities:
* Lead and coordinate investigations into manufacturing deviations, non-conformances, and changes.
* Ensure timely implementation of corrective and preventive actions (CAPAs).
* Monitor and report on trends in deviations and quality metrics.
Key Accountabilities:
* Act as the primary point of contact for GMP-related issues raised by Production, Engineering, QC, and Technical Affairs.
* Provide expert advice and input into the development, implementation, and optimization of site-wide quality systems.
* Review and approve key quality documentation, including Standard Operating Procedures (SOPs), worksheets, logbooks, and validation protocols.
Requirements:
* Degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
* Certification as a Qualified Person (QP) under EU Directive 2001/83/EC or 2001/20/EC.
* Comprehensive understanding of EU and Irish GMP requirements and regulatory frameworks.
Experience/Skills:
* Minimum of 5 years experience in a GMP-regulated pharmaceutical manufacturing environment.
* Strong knowledge of pharmaceutical manufacturing processes, quality assurance systems, and validation principles.
* Excellent analytical and problem-solving skills, with a focus on root cause analysis and CAPA implementation.
Benefits:
* Performance Bonus
* Health Insurance
* Flex Time
* Pension Scheme
* Parking Space with EV Charger
* Subsidized Canteen