QA Specialists, Manufacturing Support / Npi (12m)

CareerWise Recruitment

Cork

QA SPECIALISTS x 2 required by CareerWise Recruitment for our multinational BioTech client in Cork, there are 2 roles with one role Supporting Manufacturing and the other role in New Product Intoduction. Both roles are usually onsite but currently remote due to COVID, both initial 12 month contracts. The QA SPECIALISTS x 2 are required to join the expanding team in Cork to help support the Quality Operations unit, you will be managing compliance activities and QA operational activities related to operational project as required by Good Manufacturing Practice (GMP. THE ROLE: * Supports GMP activities from operational through to Laboratory support programs. * Partners with other Departments to ensure that compliance programs are completed in an efficient manner and are effectively maintained. * Responsible for implementation of systems and procedures for the management of change control and deviation management, as it applies to plant installations, systems, and operations in accordance with GMP. * Quality oversight of project activities including but not limited to, C&Q activities and process validation through to commercial manufacture. * Participates as a key quality member in inspections and audits by external parties/agencies. * Key participant within the QA team in the execution of their duties. * Executes the activities of the group within quality to create a synergistic approach to goals and tasks. * Domestic and international travel may be required. REQUIREMENTS: * To Bachelors Degree in a scientific/technical discipline required. * A minimum of 3 years experience in a quality or compliance role within the biological and/or pharmaceutical industry. * Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. * Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position. * Demonstrated knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities. * Focus on patients and customers at all times. Please call Conor Twomey today for further information on 087-0907204 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.

827 days ago