Qualified Person S010631

Manufacturing & Logistics | |
JOB TITLE:Qualified Person S010631
REF NUMBER:Qualified Person S010631
SALARY:
JOB DESCRIPTION:

RecruitmentPlus has an excellent opportunity for a Qualified Person based in City North, Ireland.

Ref: S010631

 

Benefits:

  • Attractive package on offer for the successful candidate

 

Responsibilities will include:

  • 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.

  • Review batch documentation from Production to ensure that the entire process has been performed according to 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.

  • 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.

  • Through direct involvement in the existing 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.

  • 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

  • Compile new and update existing technical agreements, support the Quality team in implementation of new product introductions and any other duties required by the Head of Quality

 

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.

 

 

If you have the relevant qualifications and experience and are interested in this role, please contact Kevin on 042 9356910 or email your up to date CV to kevin@rplus.ie

 

Should you choose to apply for this vacancy – RecruitmentPlus will screen your CV for this vacancy and any other suitable positions of a similar nature.

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Qualified Person S010631

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