Up to €51.92 per hour DOE
CK Group is recruiting for a Technical Writer to join a company in the Pharmaceutical industry at their site based in Dun Laoghaire on a 12 month contract basis. Pay rate is up to €51.92 per hour LTD.
- The Company:
- Our client is one of the worlds leading manufacturers of biosimilar and biopharmaceutical products used in the treatment of a wide range of human healthcare conditions from cancer to arthritis. This company are a strong believer in helping patients by developing new treatments and taking them to market via their global network of specialist aseptic manufacturing, packaging and distribution sites.
- The Location:
- This role is located on a state of the art manufacturing facility based in Dun Laoghaire and is a quick 30 minute drive away from the centre of Dublin, or 60 minutes drive from Dublin Airport. The site is easily commutable from Kildare or Wicklow by car and there is a good public transport network if you would prefer to live within Dublin itself. Dun Laoghaire is a vibrant cultural hub in south Dublin which is best known for its maritime history and locally caught sea food.
- The activities performed in the role of Technical Writer include:
- Develop, review and update engineering, manufacturing, & inspection Standard Operating Procedures.
- Liaise with Manufacturing/Inspection/Engineering regarding documentation changes in an effective and timely manner.
- Develop protocols for execution in Manufacturing & Inspection in support of change controls, non-conformances & troubleshooting investigations with support from relevant SMEs.
- Involvement in projects as part of continuous process improvement and / or troubleshooting
- Ownership of change controls for Manufacturing/Inspection/Engineering
- Issuance and updates of paper batch records in line with production schedule.
- Liaise with Quality Assurance to ensure that GMP standards are maintained in line with current OS
- Support production support team in reducing document turnaround times.
- Use specified software packages and standard procedures, responsible for compiling and maintaining all relevant documentation including SOPs.
- Provide technical and clerical support to the manufacturing, inspection & engineering teams in the preparation of documentation, collation of data and tracking of SOPs
- Ownership of Level 1 non-conformances
- Your Background:
- Educated to degree level or equivalent.
- Significant experience in Chemistry/Microbiology/Engineering/Validation gained within a biotech, pharma or health care organisation.
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 46416 in all correspondence.
Posted 23 days ago