Compliance Specialist (12m, Bio)

CAREERWISE RECRUITMENT

LIMERICK

COMPLIANCE SPECIALIST required by CareerWise Recruitment for our BioTech client in Limerick, role will be based in the Technical Operations department (Automation, Engineering & Facilities. The COMPLIANCE SPECIALIST will have a minimum of 3 years experience working in a cGMP environment and will initiate & coordinate root cause analysis and authoring of Technical deviation investigations on the quality management system. The COMPLIANCE SPECIALIST ensures CAPAs are identified as appropriate and are implemented as planned; in addition, ensures CAPAs have the intended effectiveness. THE ROLE: * Acts as a liaison between Technical Operations and onsite quality and regulatory groups, as well as other departments across the company, with respect to all quality instances and compliance support. * Provides support, information, and assistance to individuals, groups and management with the initiation, authorship, review, submission, and follow-up/completion of documents such as Change Controls, risk assessments, impact statements and corrective/prevention action plans. * Reviewing and maintaining procedures, polices and other instructional documents with a focus on continuous improvement. * Provide periodic review of department documentation and records such as Periodic Evaluation Reports (PER), logbooks, Life Cycle Documents and Engineering Documetation, etc. to assess for compliance with established quality standards, policies and procedures. * Review and approval of preventative maintenance records/work orders (corrective and scheduled) on the CMMS system to assess for compliance with established quality standards, policies and procedures. * Provide tracking and trending for maintenance of related compliance activities i.e. quality instances and PERs. * Participate in audit activities, prepare and implement responses and corrective actions and obtain results for actions for all Technical Operations quality and regulatory audits. * Maintains knowledge of current good manufacturing practices (cGMPs) and execution of any other GMP compliance related activities as required. REQUIREMENTS: * Primary degree in Science/Engineering discipline. * Minimum of 3 years experience working in a cGMP environment. * Excellent written, presentation, communication and investigation skills with the ability to engage with a diverse range of individuals across all levels of the organization. * Ability to work on own initiative, without direct supervision from management. * Proficient in MS Office (Word, Excel, Outlook, Access and PowerPoint. * Knowledge of Electronic Data Management Systems is an advantage. 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.

1379 days ago