Documentation Specialist
- Ireland, Cork
- Contract
- CAPEX Projects
The site has received €130 million in investment over the last five years to continue the growth and expansion of the facility; with new products coming to the site, it is an exciting time to join the team.
Bring energy, knowledge, innovation, and leadership to carry out the following:
- Creating, editing, and formatting of SOPs, Work Instructions, and other documents on the EDMS (Veeva Vault) from material supplied by the Vaccine IPT SMEs.
- Liaison with key stakeholders e.g., Quality, Change Control, SMEs etc. to ensure compliance, correctness, content, and delivery.
- Lead the tracking and maintaining of the project document delivery schedules for the team (using Excel).
- Engage with Change Control and the wider project team to ensure documents are prepared and updated in time for different stages of C&Q execution and production.
- Provides to the site knowledge and experience in Quality Documentation Systems.
- Responsible for use of the Site Documentation System including Issuance, reconciliation, storage, archiving and retrieval of cGMP documentation to support the manufacture & testing of our products.
- Responsible for maintaining the Site Master file for current effective cGMP documents on site at Brinny.
- Uses knowledge to improve Quality Documentation Systems, solve problems, provide continuous improvement, and execute tasks.
- Provides compliance contribution to project teams and leads small projects.
What skills you will need:
- Experience as a documentation specialist or equivalent in a pharmaceutical or a highly regulated environment.
- Experience in maintaining and updating excel schedules and trackers for small projects.
- Advanced PC skills such as Excel, Word, PowerPoint.
- Stakeholder management of multi decision makers, colleagues, peers, and cross functional teams.
- Knowledge and experience of GMP and GDP in a pharmaceutical environment.
- Desirable: Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g., Manufacturing, Quality, Engineering, Tech Services etc).
- Desirable: Qualification in a biological science subject.
- Desirable: Evidence of Continuous Personal Development.
If this role is of interest to you, please apply now!
#LI-JS5
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
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