Tenni Cole-Etti is currently recruiting for a Technical Writer to join one of the world's premier innovative biopharmaceutical companies in Kent, discovering, developing medicines, vaccines and consumer healthcare products. This role is offered on a contract basis for 12 months, with the possibility of extension.
This role will be based within the Materials Characterisation Team that support the Company with ICP-MS elemental impurity testing in order to meet new ICH Q3D guidelines by January 2018. The company's commitment is to complete ICP-MS testing for all drug product families and support this with a full paper based risk assessment.
Your main responsibilities in this role will be to:
- Complete paper based risk assessments for all drug products tested in the hub.
- Author the required documents in partnership with site project leads
- Provide the scientific rationale for presence of ICH Q3D elements based on information gathered about the process, product storage and the product formulation and combine this with drug product testing and Permitted Daily Exposure limits for a definition of risk to a product family
- Develop, author and implement the necessary risk assessment documents to ensure the team are aligned with ICH Q3D guidance and Internal Quality Systems
- Work with the subject matter expert in the team and site project lead to gather and process all relevant documentation required for the risk assessment
- Work collaboratively with all team members, customers and stakeholders to deliver a dynamic paper based risk assessment fit for regulatory inspection
- Experience and knowledge of ICP-MS for elemental analysis is preferred but not required
You are required to have the following qualifications, skills and experience:
• BSc in a relevant scientific discipline
• Previous experience within a similar function, would be beneficial
• Knowledgeable with drug delivery devices is essential
• Experience within the pharmaceutical industry is ideal
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 who 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 ST39577 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group (Science, Clinical, Engineers and IT Recruitment)
- Posted: 13th July 2017
- Expires: 10th August 2017
- Reference: ST39577