Tenni Cole-Etti is currently recruiting for a QA Specialist to join the world's largest biotech company, a leader in personalised medicine, a leading provider of cancer treatments and the market leader of in vitro diagnostics at their site in Hertfordshire on a full time temporary basis until December 2018 with the possibility of extension. As a global leader in research-focused healthcare they are constantly learning and growing and seeking people who share these goals.
We are looking for a Quality Specialist (GMP and GDP) who will be responsible for the administration of key batch release processes and supporting the Qualified Persons to fulfil their legal obligations.
Your main responsibilities in this role will be to:
- Carry out Batch Record Review for commercial batch disposition activities undertaken by the site
- Look after activities relating to the assessment of returns of medicinal product back into saleable stock
- Assist with the assessment of temperature monitoring of stock related to both chilled and ambient deliveries
- Raise, write and assess deviations
- Manage group e-mail accounts and track logs
- Perform or support Quality Assurance activities (e.g. recalls, report writing, incident investigation, document preparation and review) as required
- Report Customer complaints
- Write CAPAs
- Provide KPIs/metrics and trending data the Quality Unit processes as required
- Provide day to day support for Rx Logistics and Customer Care regarding GMP and GDP activities
- Undertake other duties as assigned by the Quality Operations Manager
You are required to have the following qualifications, skills and experience:
- Life sciences degree (BSc, MSc, or equivalent) within a Scientific, Medical or Healthcare discipline is essential
- Experience working in Good Manufacturing and Good Distribution Practice requirements
- Previous experience within a Quality Role
- Relevant experience with Microsoft applications (e.g .Word, Excel, Powerpoint, Visio) and others as applicable (e.g. SAP, Trackwise)
- Good knowledge of ICH GCP
- Project management skills
If you are successful you will be joining a global biotech company based in Hertfordshire.
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 ST39783 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group (Science, Clinical, Engineers and IT Recruitment)
- Posted: 9th August 2017
- Expires: 6th September 2017
- Reference: ST39783