My client a leading and rapidly expanding Pharmaceutical Company now require a Quality Compliance Lead to join their rapidly expanding team.
The Quality Compliance Lead 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 Lead
- Supervisory duties for Quality Compliance personnel within the Quality Compliance group.
- Provide oversight and management of elements of the Quality Management System (QMS), which includes, but not limited to, inspection management, metrics/KPIs, Product Complaints, Quality council, product quality communications, Regulatory Compliance, commitment and risk management.
- 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 8 years working within quality in the pharmaceutical industry.
- A minimum of 3 years’ experience in a people management role is desirable.
- 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.
The RFT Group, BioPharmaceutical Division specialize 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