QP Ireland
- Reference: JLSEQP
- Location: Ireland
- Salary: Euros 115000
- Type: Full time
- Start: ASAP
Just Life Sciences are seeking a QP for their Pharma client in Ireland, this is a remote role, with only attendance at site when they are Client Visits.
Qualifications, Skills and Experience
- • Provide the Quality management team with direct support and guidance in all quality matters as directed by the Quality Director to ensure that Quality operations meet the requisite safety, quality and cGMP requirements
- Quality Operations
• Review batch documentation from Production to ensure that the entire process has been performed according to Group 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 Group 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 - Qualifications / Skills Requirements:
• Bachelor’s degree in Science, Engineering, Technology, or a related discipline
• Qualified Person status or eligibility for QP status
• Minimum 3-5 years’ experience in a quality management role in the Pharma Industry
• Extensive quality systems and quality operations experience
• Strong organisational / time management skills
• Effective interpersonal communications, leadership, and people management skills. - Interested? Then please email your CV to justyn@justlifesciences.com
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Just Life Sciences
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2a Foster Drive,
Cardiff,
CF23 9BZ - Mobile 07968 551450
- Email justyn.withey@justlifesciences.com
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2a Foster Drive,