Lana Premadasa is recruiting for a GMP & Medical Device Auditor to join a company in the Pharmaceutical industry at their site based in Wiltshire on a permanent basis and a salary of £50,000 per annum.
Our client is an international Pharmaceutical company with more than 80 years of experience in research, development, production and the commercialisation of innovative medicines in the Respiratory, Neonatology, Rare Disease and the Special Care Therapeutic areas. They are a research focused company with the mission to develop and commercialise innovative pharmaceutical solutions to improve the quality of human life.
This role is located in beautiful Wiltshire, at the company's Research & Development centre. Here their aim is to increase productivity in early development for respiratory new chemical entities and provide integrated drug product development for inhalation products and to get faster to clinical proof of concept.
Your main duties will be:
- Execution of audits to CRO/CMO in charge of GMP manufacturing and control of IMP.
- Execution of audits to Medical Devices Providers.
- Finalisation of audit reports following the audits.
- Management of CAPA plans.
- Finalisation of Quality Agreements.
- Write and review SOPs; monitor the continuous updating process of SOPs to ensure agreement with regulations and internal procedures.
- Ensure good documentation and traceability.
- Review and approve documents related to out-sourced GMP activities and to the out-sourced activities for medical devices.
- Ensure training on relevant activities and procedures.
The ideal candidate for this role will have the following skills and experience:
- Degree (or equivalent) in a Scientific degree.
- Experience in Quality Assurance / Auditing GMP and medical devices.
- Knowledge of GMP, medical device regulations and working to ISO9001/ISO13485/ISO14971.
- Annual discretionary bonus (based on performance).
- 25 days annual leave.
- Group personal pension scheme with flexible contributions and employer pension contribution.
- Private Medical and Dental Insurance (including partner cover).
- Life assurance.
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 43948 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group
- Contact: Lana Premadasa
- Phone: 01438 723500
- Reference: 43948
- Posted: 10th January 2019
- Expires: 7th February 2019