Quality Compliance Specialist
My client a leading and rapidly expanding Pharmaceutical Company now require a Quality Compliance Specialist to join their rapidly expanding team.
The Senior Quality Compliance Specialist is responsible for the coordination of compliance activities within the compliance group and for varying duties as assigned by the Quality Compliance Executive. Some key tasks and responsibilities are outlined below.
This is a permanent role based in Dublin.
Responsibilities of Quality Compliance Specialist
- Assisting in oversight and management of key elements of the Quality Management System (QMS) within the compliance group, which includes but not limited to, inspection management, metrics/KPIs, Quality council, product quality communications, Product Complaints, Risk Management and Regulatory Compliance.
- Administration/co-ordination of Product Quality Complaints.
- Participate in the internal audit schedule.
- Administration/co-ordination of risk assessments.
- Develop and write SOP & Controlled Documents.
- Be a key member of the onsite audit team during external cGMP audits, e.g. from Regulatory Authorities and Global Quality.
- Preparation of Key Performance Indicators to align with company and global quality objectives.
- Assisting in, and facilitating, investigations as part of the site Deviation Management System, ensuring effective root cause analysis and assigning of appropriate CAPAs.
- Assist and co-ordinate the preparation of reports in relation to Annual Product Reviews for all products manufactured on site.
- Participation in the preparation of documentation for regulatory submissions.
- To ensure that the systems with a GMP impact are maintained as per written procedures.
- Assist in implementation of global standards and procedures into the site Quality Systems.
- To actively support the development/implementation and continuous improvement of the Quality Management Systems.
- To be cross-trained in multiple quality systems.
- Participate in other projects as directed by the Quality Systems & Compliance Manager.
- Bachelor's degree in chemistry, biology or a related scientific discipline.
- A minimum of 4 years working within quality in the pharmaceutical industry.
- Experience working in finished product pharmaceuticals/biologics, including analytical chemistry, quality assurance, quality control, development, and/or manufacturing areas.
- Thorough understanding of quality systems and cGMP's.
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For more information please contact John at The RFT Group / www.rftgroup.ie / 01 2302400 or click apply below