Our client is a highly ambitious fast growing multinational biopharmaceutical company who have a strong performing commercial portfolio along with an exciting pipeline of innovative drug compounds at an advanced stage in research.
Due to rapid expansion they wish to make an additional hire of CSV and IT Compliance Specialist in a contract role who will operate within IT Systems Manufacturing Operations function. This hire will be expected to work in a hybrid role, on site in midlands of Ireland location and flexible to work from home majority of days.
The successful CSV and IT Compliance Specialist will lead Systems Implementation / Business Transformation projects. This hands-on role will lead in the implementation of process improvements and technology implementations. Providing oversight of implementation activities and drives regular status and escalation reporting to ensure adherence to plans and budgets. Manages the full lifecycle of implementation from concept, contracting, design, build, testing, cutover and post go-live support handover.
The ideal candidate with be experience with CSV/SDLC, in leading the deployment of new technologies in the regulated Life Sciences industry; including : LIMS (LabWare), Serialisation, Process Control System (PCS), Computerised Maintenance Management System (CMMS), Building Management Systems (BMS).
- 4+ years experience in a similar role i.e. CSV / IT systems implementations in an operational Biopharma, Pharma or Medtech environment is essential.
- Experience of working in an FDA/MHRA/HPRA regulated manufacturing environment operating to cGMP standards.
- System and process improvement implementations experience in at least one of the following areas: LIMS (LabWare), Serialisation, Process Control System (PCS), Computerised Maintenance Management System (CMMS), Building Management Systems (BMS).
- Experience in CSV/SDLC methodologies.
- Knowledge of FDA CFR 21 part 11 and EU Annex 11
- Proven experience in change management, through systems, processes and/or tools / principals.
Required soft skills / attributes will include:
- strong technical computer systems understanding,
- good collaboration skills, focused on customer service and facilitation,
- effective communication and presentation skills,
- strong ability to build working relationship in a professional environment,
- understanding and competence of pharma regulations and compliance e.g., FDA, cGMP, etc.
For further details please phone Larry on +353 1-2302400 / email@example.com
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
Follow us on: Facebook, Linked-in, twitter