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Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
We are looking for a Qualified Person (Permanent role) to join our team. This is a hybrid position (Monday to Friday), and the ideal candidate should be based either in Stamullen or Dundalk.
Summary of Role:
* Provide the Quality management team direct support and guidance in all quality matters as directed by Head of Quality to ensure that Quality operations meet the requisite safety, quality, and cGMP requirements.
Key Responsibilities:
Quality Operations
* Review batch documentation from Production to ensure that the entire process has been performed according to PCI requirements, customer requirements and cGMP principles, and that it meets customer and agency audit standards.
* Disposition (back to customer QPs or directly to market) and certify completed batches effectively, investigating deviations and establishing corrective and preventive actions.
* Realise “right first time” objectives, tracking quality and efficiency standards.
* By direct observation and intervention, monitor the application of quality standards to enable quality processes, compliant documentation, timely corrective action and continuous improvement.
Quality Projects
* Responsible for quality projects to improve quality and departmental effectiveness, such as process validation, cleaning validation, cold chain storage, temperature mapping, environmental monitoring, benchmarking, KPI management, performance management and problem solving.
Quality Systems
* Through direct involvement in the existing PCI quality systems, provide guidance and support for the various elements, such as audits, training, SOPS, documentation, change control, complaints, investigations and CAPAs, to ensure on-going compliance with customer, regulatory and internal requirements.
Continuous Quality Improvement
* Develop and sustain an environment of continuous improvement through active implementation of process excellence and lean six-sigma methodologies.
* Actively promote best practice in quality methods and drive continuous improvement initiatives to improve quality, cost and cycle times.
General
* Compile new and update existing technical agreements.
* Support the Quality team in implementation of new product introductions.
* Any other duties required by the Head of Quality.
* Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
Knowledge / Skills & Experience:
* Bachelor’s degree in science, Engineering, Technology or a related discipline.
* Qualified Person status or eligibility for QP status.
* At least 3-5 years’ experience in a quality management role in the Pharma industry.
* Sound industry knowledge of the requirements of EU GMP and the IMB.
* Extensive quality systems and quality operations experience.
* Strong organisational / time management skills.
* Effective interpersonal communications, leadership and man-management skills.
* Experience of working at management level within a similar environment.
* High motivation, flexibility and the ability to work under pressure and on own initiative.
* Proven track record of showing how results were delivered through management/leadership of others.
* All employees are required to satisfactorily perform the essential duties and responsibilities of their position.
* The essential duties and responsibilities listed above are not intended to be an exhaustive list of all responsibilities, duties and skills required.
* Experience in Lean Manufacturing, including experience in Lean tools to develop continuous improvements.
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Join us and be part of building the bridge between life changing therapies and patients.
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