Our Partner in Tipperary area develops and supplies the active ingredients and final formulated product for a range of innovative medicines at its manufacturing and R&D facilities. The plant, which has been operating in Tipperary for over 40 years, exports to over 25 countries around the world with primary markets being Europe, USA and Japan. They are searching for a Documentation specialist to join the team on a contractual basis.
Essential Duties and Responsibilities for this Documentation Specialist role include, but are not limited to, the following:
- Link with project team to develop project change control documents.
- Review any queries that may arise from project change control committee.
- Generate action list and assign actions on track-wise and review until closure
- Updating/deletion of documents through the MIDAS system
- Processing of documentation through the Change Control System
- Ensure Handover Packs from vendor/contractors contain the required information – issue deadline date to vendor/contractors for packs
- Compile change control packs and circulate for approval
- Prepare Documentation Handover Section – (warranty etc.)
Requirements as a Documentation Specialist are:
- Experience working in Pharm/Bio Pharm industry with experience in project activities in documentation control
- Understands the typical project life cycle from concept through to qualification and has proven experience in this area.
- Familiar with engineering project management tools
- Proven knowledge, appreciation, and experience of working in regulated GMP environment.
- A degree in engineering, quality, or science is preferred.
If this role interests you, send over your CV or apply today!
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
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