|Job Title:||Quality Manager|
|Contact Name:||Laurentina Kennedy|
|Job Published:||over 4 years ago|
Our client is an international pharmaceutical group specialised in medical imaging, is directly present on most of the world's markets.
The Quality Manager reports to the Group Director Quality Technical Operations/Chief Pharmaceutical Officer with dotted line responsibility to Site Director.
The purpose of this role will be to lead and be responsible for overseeing all QA/QC efforts & GMP activities.
The Quality Manager will be responsible for all aspects of GMP Quality Assurance, including developing operating philosophies, establishment and maintenance of a Quality Culture and establishing quality systems in alignment with Global Standards and international GMP regulations.
Lead the GMP compliance efforts for API production process related to site
Monitor and audit manufacturing for GMP compliance and serve as a key resource to production regarding quality and compliance issues.
Develop, manage, and maintain appropriate procedures to ensure regulatory compliance.
Establish and maintain key quality indicator elements, organise quality goals and objectives.
Identify, assess and incorporate best-demonstrated industry practices to assure GMP and regulatory compliance with all relevant Health Authorities (HA) and applicable external regulatory requirements and applicable guidance documents.
Assure that Quality Systems are managed and continuously reviewed and improved for regulatory compliance and operating efficiencies.
Manage and support all HA and other regulatory agency activities including inspections, inquiries, notifications, all and other agency associated activities.
Apply modern principles of quality systems and strategic planning to products and processes to achieve sustainable quality and compliance performance.
Establish and/or improve monitoring measures for key elements related to quality goal attainment.
Analyse and report product and process quality trends, and quality system integrity against internal and external guidelines, standards and regulations.
Supervise Quality Assurance, Quality Control, Drug Product Release and Training functions.
Develop and conduct training for quality and other personnel, as necessary. Ensure that quality department personnel are trained to perform their jobs effectively and ensure an efficient operation that is well integrated.
Recognise the need for investigation due to deviation from written procedures, conduct investigation into non-conformance, incidents/deviations and recommend disposition of the affected product/component.
Prepare trend reports related to in-process monitoring, deviation reports, investigation reports. Follow up with the functional department for timely completion of corrective and preventive actions recommended.
Define/Perform annual and random audits of production, warehouse, maintenance, analytical laboratory, etc.
Recommend continuous improvement plans based on observation of process, vendors, data, etc. to management.
Ensure timely in-process/final testing of drug products.
Notify any problems with in-process testing results to production immediately and investigate the incident, as appropriate.
Maintain a thorough knowledge of appropriate standard operating procedures and applicable regulatory requirements and guidance documents.
Perform personnel evaluation as needed.
Develop and manage to the financial budgets for overhead and staffing.
Perform other related duties as assigned from time to time based on company needs.
Education & Experience:
Bachelor's Degree in chemistry, engineering or pharmacy with 10 years' experience in an API/Pharmaceutical Quality Assurance/Quality Control environment.
Five (5) years of progressive leadership or supervisory experience in a Quality Assurance function of the pharmaceutical industry required.
Knowledge and experience of applicable regulatory standards and requirements for the API manufacturing required - EU and US FDA, ICH Q7a...
Knowledge of analysis of API utilising UPLC/HPLC, GC, spectroscopic and wet chemistry techniques & microbiology.
WW/EU/USA APIs regulatory compliance & GMPs, GMP Quality Assurance, QA, good manufacturing practices, auditing, inspection hosting, packaging, Quality Operations, Quality Control, plant floor, Operational Excellence/Continuous Improvements QA team leadership, batch record review, batch release, product disposition.
For further information on this Quality Manager position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / Laurentina@rftgroup.ie. Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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