Senior Qualified Person - QP Key Responsibilities: 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, ensuring alignment with product Marketing Authorizations (MA).
Lead and coordinate investigations into manufacturing deviations, non-conformances, and changes, ensuring timely implementation of corrective and preventive actions (CAPAs).
Monitor and report on trends in deviations and quality metrics, supporting continuous improvement initiatives.
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.
Ensure product release procedures and quality systems comply with current regulatory requirements and company policies.
Participate in internal audits and supplier qualifications, ensuring compliance with GMP and contractual obligations.
Act as a representative during regulatory inspections, including HPRA and other authorities, ensuring a successful audit outcome.
Contribute to the maintenance and improvement of the Pharmaceutical Quality System (PQS), driving continuous compliance across all operations.
Stay informed about regulatory and industry developments, advising on their implementation within the organization.
Participate in company projects and cross-functional initiatives to enhance overall quality compliance and operational efficiency.
Qualifications: 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.
Proven experience in batch certification and release of pharmaceutical products.
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.
Effective communicator, capable of interacting with regulatory bodies, internal teams, and external partners.
Experience with regulatory inspections, including HPRA audits.
Strong attention to detail and organizational skills.
Familiarity with electronic Quality Management Systems (eQMS) is an advantage.
Helsinn Birex Pharmaceuticals - we are a global pharmaceutical company and a leader in supportive care focused on improving the health and quality of life of patients with cancer and chronic diseases.
For more information, please visit our company website , Skills: Batch Release Quality Assurance Risk Assessment Deviation Investigation Documentation Review Pharmaceutical Quality Benefits: Performance Bonus Health Insurance Work from Home Flex Time Pension Scheme Parking Space with EV Charger Subsidized Canteen