Our client, an established FDA regulated company are looking for a Qualified Person to join their team on a 12 month contract. The Role: • Site Qualified Person responsible for the release of medicinal product to markets. • Perform duties in a compliant manner and behave in accordance with the Quality Management System requirements. • Participate fully in the site’s quality initiatives and ensure that all relevant quality standards are adhered to. • Maintain GMP standards where appropriate. • Read and understand relevant Standard Operating Procedures and Global Quality applicable to role. • Attend training and complete assessments as required. • Advocate for quality. • Ensure Quality and GMP are at the forefront of changes proposed. • Deep understanding of regulations and ability to translate into compliant effective processes. • Experience of Change management and understanding of change control process. • Communication skills across site and organization. • Understanding of appropriate directives, standards and QMS systems relating to the manufacture and supply of medicinal products. • Understanding of Risk Management. • Understanding of Customer Complaint and Deviation Processes. • Manage a team of approximately 4 in the plant. • Excellent communication/interpersonal skills with a strong affiliation with customer support. • Work within a value/product stream environment. • Assist all Quality and Manufacturing functions in preparation for and during external agency audits and internal company audits. The Role: · 5 yrs experience in a pharmaceutical/ healthcare company. · Understanding of appropriate directives, standards, policies and guidelines and ability to implement appropriately, · Directive 2003/94/EC. · Eudralex Volume 4 - Annex 16: Certification by Qualified Person and Batch Release. Directive 2001/83/EC e.g. Article 47 of Directive 2001/83/EC, Article 51 of Directive 2001/83/EC and Article 51(2) of Directive 2001/83/EC, as amended. · QMS. · EU GMP. · cGMP. · Understanding of relevant regulatory requirements for all markets. · Understanding of quality systems. Hartley People Recruitment work to the highest ethical standards within our industry and we value the trust that you place in us when you send your CV. We can provide a full consultation in confidence and we guarantee that your CV will not be sent to any of our clients without your prior consent. For immediate consideration please call Pairic on 051-878813 or email your CV in response to this job posting. Hartley People also recruit for similar roles such as Analytical Chemist, Quality Control Manager, Quality Control Technician, Quality Assurance Technician, New Product Development Manger, Quality Systems Manager, Formulation Scientist, Development Technologist.
Waterford, Tipperary, Cork
111 days ago