Documentation Specialist - Brinny, Innishannon
Posted on Jan 29, 2019 by Anonymous
Our client is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. This position sits within their Manufacturing Division, which consists of a team of dedicated, energetic individuals, committed to being the most trusted supplier of pharmaceuticals and health products worldwide. They have an interdependent global manufacturing network that's committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
The role, will be working at our clients site in Brinny which is situated in Cork in South West Ireland. The site is just 30 minutes drive from the centre of Cork and is accessible by bus too.
The Documentation Specialist is accountable for the smooth execution of all appropriate documentation associated within Technology CoE.
- Contributing to the High Performance culture within Technology CoE by providing a flexible, accurate service to enable the department to achieve MMD four key priorities.
- Acting as an active member of the team, providing support, guidance and expertise to ensure the success of the department.
- Updating of procedural documents.
- Preparation of change control documentation.
- Processing of documentation through the Change Control System.
- Review of batch records and recording of incidences of corrections made to batch records.
- Generation and control of protocols.
- Quality & Safety Compliance monitoring including reporting, metrics, etc.
- Investigation Support.
- Issuance of documents to the Operations Department.
- Any other duties assigned by your lead.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- 2+ years' experience of working in a similar documentation related role in the Pharmaceutical Industry.
- Knowledge of EU/US quality related pharmaceutical regulations.
- Qualification in Science or related discipline preferable.
- Computer literacy is essential.
- Strong communication skills.
- High level of technical aptitude.
- Demonstrated initiative and pays attention to detail.
- Good presentation skills.
- Highly disciplined and organized.
- Ability to organise & coach less experienced colleagues in the group.
- Ability to work as part of a team.
Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference KA44456 in all correspondence