UK ~ Reading
GMP Document Specialist
Our growing and successful business comprises of over 700 talented individuals globally, in an environment where everybody counts and is instrumental to our success. With state-of-the-art manufacturing and clinical facilities in the UK and USA, we deliver a full range of drug development solutions around the globe saving our clients both time and money. People join Quotient Sciences because we are a respected member of the drug development world, specialising in delivering innovative solutions that integrate formulation development, real time GMP manufacturing and clinical testing. We pride ourselves on the quality of our services and our engaged culture. We are passionate about helping our customers get new medicines to market.
We have an excellent opportunity for a GMP Document Specialist working in the Pharmaceutical Scientific and Technical Services area. You will take the lead in Clinical Trial Project Packaging and be responsible for providing project support for the Pharmaceutical Operations working alongside colleagues in Project Management.
The key responsibilities of the role are outlined below.
- Drafting & reviewing of batch manufacturing/packaging records and associated controlled labels for the business.
- Critically review final batch records and labels and contribute to the maintenance of the PSF files.
- Assist in the progression of IMP, clinical trial labelling and manufacturing services within Quotient Sciences.
- Take Project Leadership responsibilities for assigned Clinical Trial Product packaging operations.
- Take responsibility for Clinical Trial Product Shipments and maintaining supporting Shipping Record files used for logging shipments.Also maintain client electronic logs covering re-supply of CTP and shipments.
- Maintain your training record and to discuss any needs with your line manager in order to maintain your knowledge
- Undertake such duties as are required for the smooth running of the company or as requested by the Vice President.
- Support Project Management as required e.g. with client meeting minutes, maintain PSF files, arranging meetings etc.
- Work safely within H&S guidelines and in accordance with company procedures.
The ideal candidate will be educated to a minimum BSc or MSc. in Pharmaceutics, Pharmacy, or other related science with a minimum of 5 years post BSc or 2 years post MSc experience in drug development and/or manufacturing of IMP products, have knowledge of GMP procedures. Previous formulation, process development and/or cGMP manufacturing experience in the pharmaceutical industry would be an advantage. You must be an organised individual, have a high attention to detail and should be able to work towards strict and tight project deadlines. The ability to juggle a range of tasks simultaneously and responding to client and internal demands is also essential for this role.
In return you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.