Qualified Person About the Company My client is operates a state of the art, world-class pharma manufacturing, packaging and release site in Dublin.
They have an exciting opportunity for an experienced QP tobe at the forefront of quality assurance, leading critical processes that directly impact patient safety and product excellence.
About the Position In this role, youll work in a collaborative, state-of-the-art facility, surrounded by passionate professionals, and play a pivotal role in driving regulatory compliance, continuous improvement, and operational success.
If youre looking for a role that combines technical expertise, leadership, and meaningful impact, this is your chance to shine!
Key Responsibilities Certify and release batches of pharmaceutical products 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 optimisation 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 organisation.
Participate in company projects and cross-functional initiatives to enhance overall quality compliance and operational efficiency.
Experience/Requirements 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.
Remuneration Package A competitive package is available including generous salary and benefits.
Contact Please contact me on or simply click the apply button.
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