Job Description
My client a leading Multinational Healthcare Manufacturing company now require a Quality Manager to join their expanding team.
Reporting to the Managing Director the Quality Manager is responsible for the management, direction and co-ordination of all quality activities across the site.
This is a permanent role based in Dublin.
Responsibilities of a Quality Manager
To ensure compliance with the requirements of Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP)
? To oversee and direct the management of the QA, QC, and the QP function.
? To ensure that adequate resources and appropriately trained and experienced personnel are available to manage the Quality System
? To manage the plant recall procedure.
? To oversee plant validation.
? To ensure adequate records are in place to provide full traceability.
? To ensure all GMP critical SOPs and batch records are approved by the Quality Department and to ensure that all Quality documentation is maintained up-to- date and compliant with cGMP.
? To lead all Regulatory and Customer GMP Inspections and to manage related follow-up activities.
? To manage the site internal auditing procedure.
? To approve and monitor contract manufacturers and contract testing laboratories.
? To be the contact person for interactions with the HPRA and other Regulatory Authorities as required.
? To act as Management Representative and to manage the maintenance of the Quality System as required by the Medical Device Regulations.
? Review customer complaints and modify processes as necessary to eliminate defects.
? Manage quality metrics across the site and ensure adherence to site quality targets.
? Drive key changes and continuous improvement in site Quality systems and procedures.
? To manage and guide the activities of the Quality Management personnel and to monitor and review performance.
? To perform the role of Responsible Person overseeing the wholesale activities in compliance with WDA licence.
Requirements of a Quality Manager
A minimum of 8 years post-graduation experience in Quality environment with at least 3 years in a management role.
? A third level qualification in a scientific discipline and relevant experience in the pharmaceutical industry.
? In addition you must have fulfilled the education requirements for the role of the Qualified Person.
? Good organisational ability and initiative to be able to work to and meet deadlines in a result orientated environment.
? Strong leadership skills and the ability to work in cross-functional team environments, as well as independently.
? Knowledge of lean systems and tools
? Experience of continuous improvement within
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The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.
For more information please contact John at The RFT Group / www.rftgroup.ie / 01 2302400 or click apply below