QA Compliance Manager (Carlow)

Careerwise Recruitment

Carlow

QA COMPLIANCE MANAGER required by CareerWise Recruitment for our multinational pharmaceutical client in Carlow. The QA COMPLIANCE MANAGER will be responsible for ensuring that the process for the manufacture of Vaccines and Biologics are in compliance with cGMP and the associated regulatory requirements. THE ROLE: * Responsible for ensuring that there is an effective Quality Management System is in place. * Ensure that objectives are effectively achieved, consistent with requirements to ensure compliance, safety and reliable supply to our customers. * Drive compliance direction for the site by ensuring adherence to divisional policies and guidelines as well as regulatory requirements. * Lead proactive evaluation of site compliance against emerging regulatory trends. * Identify and lead major compliance initiatives to improve compliance status and overall operational efficiency of the site. * Actively participate and in Plant/Quality committees and works with other site functional groups, such as the EC Laboratory, Production, Utilities, Site Services, and Maintenance to help set direction for plant wide GMP initiatives. * Partner with colleagues cross functionally to provide support and advice on day to day basis and on a project basis including communications, training, project work, audit/inspection duties, investigations, batch work, customer queries etc; thereby ensuring department is audit/inspection ready. * Ensure that quality issues are identified, addressed and resolved before activities commences. * Responsible for supporting deviation and atypical close out and initiating/following up on corrective and preventative actions. * Lead the effective implementation of the Quality Management System, and facilitate the continuous improvement of same ensuring the Quality Management Systems are accurate and complete. * Be an advocate of continuous improvement in the Quality Management Systems. * Initiate and maintain Quality related metrics, ensuring effective communication and follow up of same. * Represent the sites Quality Management System during Board of Health and other GMP inspections. REQUIREMENTS: * Third Level Degree qualified in a Science/Technical or related discipline. * 5 years' experience in a similar role in the Pharmaceutical industry managing teams. * Relevant experience and a particular skill set in their area of expertise that adds value to the business; ideally in a manufacturing, preferably GMP setting. * Advanced leadership skills including ability to lead across function team and work across boundaries. * Communication, decision making, people influencing and project management skills will be important. * Critical to success will be an expert level of knowledge of cGMP and Quality System regulations. Please call Conor Twomey today for further information on 021 4297422 or email: ctwomey@careerwise.ie. CareerWise Recruitment (In Search of Excellence. Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent. This job originally appeared on RecruitIreland.com.

2070 days ago