Documentation / Change Control Officer

Careerwise Recruitment

Sligo

A Documentation Change Control Officer is required by CareerWise Recruitment for a leading company based in the North West of Ireland. If you are interested in joining a progressive and expansive company, then this is the job for you. THE ROLE: * Coordination of activities to control documentation required by ISO013485 standard and regulatory requirements. * Ensures Process Owners are clearly continuously identified and request to Plant Manager replacement or assignment of Process Owners when needed. * Owner of Documentation Control sub process and author of related documents including procedures forms and templates. * Creates documentary in the department to centralise products documentation (DHF, DMR and Master DHR. * Clarifies documentation structure to be used for QA/RA directories. * Transfer in history files, files not anymore part of QA activities under control. * Be the subject matter expert in the Documentation Control procedure and Good documentation Practises & Electronic Documentation Control Systems. * Defines change control process with Compliance & Validation, make sure Its implementation adequately and purposes suggestions to improve change control. REQUIREMENTS: * Degree / Diploma Qualified in a Quality Discipline. * 3-5 year's experience within a manufacturing preferably medical device industry. * Strong understanding of GMPs related to Change Control and Documentation Control. * Good computer skills including but not limited to Microsoft Office tools and e-Documentation Control System. Please call Louise Mulligan today for further information on 094 900 3979 or email: lmulligan@careerwise.ie. CareerWise Recruitment - In Search of Excellence. CareerWise Recruitment specialises in the multinational sector in Ireland which predominantly encompasses the Medical Device, Sciences/Pharma and ICT industries. We also work into the Indigenous Engineering and Food Processing/Agri sectors. Established in 1999, CareerWise Recruitment is recognised by many of the major indigenous and multinationals companies to be one of Irelands leading specialist Technical and Executive Recruitment firms. We operate out of multiple locations in Ireland and have offices in Mayo, Cork, Shannon, Galway and Dublin. This job originally appeared on RecruitIreland.com.

2304 days ago