Technicial Transfer Lead
CAREERWISE RECRUITMENT
DUBLIN
Senior Technical Transfer Lead is required by CareerWise Recruitment for our Dublin based client. This is a 12-month contract. If you are interested in Drug Product Manufacturing then this is the position for you. THE ROLE: * Development of validation plans, process performance qualifications for vial and syringe filling. * Ensuring all aspects of activity within any given process validation adheres to required policies and procedures, including safety and training. * Ensure that the site meets the quality requirements of its customers and applicable regulations (FDA, EU & international standards) with a full understanding of CMC business process related to technology transfer. * Participate in process validation cross functional teams at the site to ensure adherence to required policies and procedures and be responsible to deliver against organizational goals and project milestones. * Pre-approve and post-approve process validation protocols and assessments from a quality system documentation perspective. * Act as the responsible point contact from site for the transfer project for drug product teams and Global Operations Teams. * Assist in the development of any existing validation program to ensure continued compliance to the necessary regulations and input to site validation guidance documents. * Collate and report on relevant shipping and filter validation. * Assist in deviation and exception resolution and root cause analysis. * Contribute to product quality assessments and process flow documents. REQUIREMENTS: * Third level Bachelor's degree in science, engineering or a relevant quality discipline with 5 years experience in a similar role OR Master's degree & 3 years of directly related experience OR Associate's degree & 10 years of directly related experience. * Strong knowledge of Quality systems, Drug Product Manufacturing and Validation. Please call Louise Mulligan today for further information on 0949003979 or email: lmulligan@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.
1546 days ago