Qualified Person - Quality Assurance - Haverhill, Suffolk
We are in search of a Qualified Person (QP) to support a Brexit project in Haverhill, working with a major pharmaceutical business. This is initially a 12-month contract.
The primary purpose and legal responsibility of this Qualified Person is to certify batches of Medicinal Product prior to release for sale and placing on the market. However, the wider technical, ethical and professional responsibilities and obligations in terms of Patient Safety, Quality and Efficacy are also considered and therefore key to the Qualified Person role is reference to the professional Code of Practice for QP's in the Pharmaceutical Industry, which is designed to take account of these issues.
You will be reporting to the Head of Product Quality Assurance
Undertake QP responsibilities for Pharmaceutical Injectables and ensure compliance of the site operation within the requirement of the Manufacturing License's and appropriate Marketing Authorisations, as defined in Directive 2001/83/EC as amended by 2010/84/EU and the Code of Practice for Qualified Persons issued under the auspices of the Institute of Biology, the Royal Pharmaceutical Society and the Royal Society of Chemistry as appropriate.
Ensuring that as a professional Qualified Person, you undertake Continuous Professional Development as appropriate and ensures that their knowledge of the medicinal dosage forms, manufacturing processes and the relevant cGMPs are current and up to date.
Ensuring that your personal technical and professional knowledge of all the relevant company processes and Quality Management Systems is sufficient for you to undertake and discharge your duties as a QP at Haverhill site and in particular with respect to your knowledge of the upstream manufacturing activities on which you must rely in certifying and releasing finished products.
· Coordinating the timely release of product for European supply for all therapeutic products
* Coordinating the timely release of product for worldwide supply for all polyclonal products
* Ensuring suitable contracts and technical agreements are prepared and implemented relating for example to the manufacture, packaging, testing and distribution or medicinal products.
* Coordinating with Manufacturing sites and Regulatory Affairs to provide support for licence submissions
* Reviewing CMC requirement to ensure correct distribution practices.
* Provide support to Corporate Compliance in the auditing of our Client facilities, contractors and key suppliers against Marketing Authorisations and European GMPs.
* Inspect contractors' facilities and production documentation at intervals to establish and maintain working relationships with people in positions or responsibility and maintain confidence in their application of European GMP and the requirements of Marketing Authorisations.
* Review and approve SOP's and other relevant GMP documents relating to the manufacture, labeling and assembly operation, storage, distribution and QC testing of medicinal products at our Client's site in Haverhill.
* To train, counsel and support staff as appropriate.
* To undertake projects as required to contribute to the improvement of site systems and processes
Must have's to be considered:
· Must be eligible for QP status under the transitional or permanent provisions and have knowledge and experience relevant to our Clients product range and manufacturing processes
· Must have experience of releasing steriles
· Must have good interpersonal and influencing skills such that good working relationships are engendered with colleagues.
· Must be able to operate calmly and effectively under the typical pressures one would expect to find in a business where a high level of patient focus and customer service is demanded
BSc or equivalent and membership of Institute of Biology, the Royal Pharmaceutical Society or the Royal Society of Chemistry as appropriate together with eligibility for QP status is essential.
Interested? We look forward to receiving your CV in due course