Quality Assurance Manager

ICDS Recruitment

Wicklow

Quality Assurance Manager. Our Client a leading Pharmaceutical company based in Co. Wicklow is looking for Quality Assurance Manager responsible for the implementation of the Pharmaceutical Quality System. Areas of responsibility will include, but are not limited to. Conducts, manages and co-ordinates the activities of the Quality Assurance function making sure a high level of motivation and qualification is maintained with the team. Drive the optimisation of the Quality function while ensuring the smooth running, performance and productivity of the Quality Assurance Department. Participate in management reviews of process performance, product quality and of the quality management system in order to identify and action opportunities for continual improvement. Ensure adequate systems are in place for the control of outsourced activities and material suppliers. Ensure the initial and continuing training of quality assurance personnel is carried out in an effective manner. Approve written procedures and other documents including amendments to those documents (eg, SOPs, WISOPs, Manufacturing records, Technical Agreements, Quality Policy and other quality related documents. Ensure a robust system for the control of documentation and record retention is in place. Co-ordinate the preparation of and follow up of regulatory and other external inspections. Oversee the internal and external audit programme and carry out audits as required. Ensure that effective systems of defect/deviation, customer complaint management and CAPA implementation are in place. Co-ordinate the preparation and submission of Quality Defect Reports to regulatory authorities as required, manage recalls as a member of the Recall Committee, ensuring mock recalls are performed as required. Lead and participate in Quality Risk Management exercises as required. Oversee the management of outsourced activities and material manufacturers and suppliers. The candidate will work collaboratively with all site departments to ensure high levels of GMP, providing quality expertise and oversight of GMP activities across the site. Act as the QP in relation to product release. This is a dynamic role where the applicants must be able to demonstrate “subject matter” expertise in their area along with a strong understanding of cGMP, compliance systems and processes. In order to be successful in this demanding role candidates will be expected to be qualified as a QP, demonstrate proven leadership ability, and management skills. Solid communication and interpersonal skills are also required. Strong attention to detail, refined planning and organisation abilities with a proven track record of multi-tasking, working to tight deadlines and delegating successfully are essential. A hands-on, proactive approach will be required. Experience in the management of change would be a strong advantage. A minimum of five years’ experience in a similar Quality role within thePpharmaceutical/Medical Devices Industry is required. Candidates should hold a Degree level qualification in a scientific or relevant discipline. This job originally appeared on RecruitIreland.com.

2584 days ago