Engineering Compliance Specialist
Careerwise Recruitment
Limerick
An Engineering Compliance Specialist is required by CareerWise Recruitment for our Limerick based client. This role will be responsible for ensuring cGMP compliance within a major multinational biopharmaceutical company. THE ROLE: * Facilitates reviews and revisions of Department related SOP's, life cycle documents, plans and policies for each group within the Department. * Acts as a liaison between onsite quality and regulatory groups to define and address compliance related items. * Identifies opportunities for continuous improvement of compliance and leads improvement initiatives. * Provides support, information, and assistance to individuals, groups and management with the initiation, review, submission, and follow-up of documents such as Change Controls, EOE's, NOE's, DNF's, risk assessments, impact statements and corrective/prevention action plans. * Participates in investigations and root cause analysis for department issues of non-compliance. * Provides periodic reviews of department documentation and records such as Periodic Evaluation Reports (PER), logbooks, preventative maintenance records/work orders, etc. to assess for compliance with established quality standards, policies and procedures. * Provides tracking and trending for maintenance of related compliance activities i.e. quality instances and PERs. * Participates in and obtains results of department quality and regulatory audits. * Specifies and coordinates training, OJT and SOP, for various departments and personnel. * Maintains knowledge of current good manufacturing practices (cGMPs. REQUIREMENTS: * Requires BA/BS (engineering or scientific related field preferred) and 3 years of related experience working in a cGMP environment or in the operation of an industrial facility. May substitute relevant experience in lieu of education. * Ability to work on own initiative, without direct supervision from management. * Team player with an ability to work well across various departments on site as well as business partners. * Excellent written, presentation, communication and investigation skills. * Deadline focused individual. Please call Gillian Dunphy today for further information on 061-365969 or email: gdunphy@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.
1741 days ago