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Scientific & Laboratory

Job Description

A Document Control Specialist is required by CareerWise Recruitment for our Waterford-based Biopharmaceutical and Medical Device Client on a 24-Month basis. Reporting to the Luna project manager as a key member of the QC Luna team, you will play an integral role supporting the QC Luna Digital Paperless project ensuring the creation, storage, issuance, and retrieval of all documentation in a manner which meets cGMP requirements. This encompasses but is not limited to QC Luna project tasks, QC Day to day activities.

Role of this position

  • Define, manage and maintain a documentation control system for QC projects and BAU cGMP documents
  • Manage, index and control the QC on-site and off-site documents
  • Create and maintain QC procedures
  • Train QC site personnel on the Documentation Management Processes and QC Luna project implementation
  • Define, manage, and maintain QC project key metrics ensuring site visibility, strong internal customer satisfaction and trending to support continuous improvement activities
  • Supporting and providing appropriate information to support Product Performance Reviews (PPR)
  • Support and report right first-time documentation findings to support continuous improvement initiatives
  • Participate in internal audits, support all external audits and any key quality initiatives
  • Ensure issuance and storage of QC and Projects documents

JOB REQUIREMENTS

  • Leaving Certificate or equivalent and will preferably have secretarial and/or clerical qualification or accreditation
  • Minimum of 3 years' experience in similar role
  • Very good knowledge of cGMP in a regulated
  • Excellent accuracy and attention to detail
  • Strong Planning/Organising skill
  • Customer Focus Driven with excellent interpersonal skills
  • Good Presentation skills
  • Working knowledge of computer systems
  • Personal development and goal management skills
  • Project Management skills and experience a distinct advantage

Please call Aisling O'Hagan-Yil today for further information on 021- 2427410 or email: aohagan-yil@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.

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Scientific & Laboratory

Cork Office

CareerWise Recruitment. EastGate Village, EastGate, Little Island, Cork.

Phone: +353 (0) 21 206 1900

Email: info@careerwise.ie