My Client a Global Biopharmaceutical company based in Suffolk is seeking a QP/Qualified person on a permanent basis.
Salary: 35-55k
Location: Suffolk
Purpose of the role:
To act as a Qualified Person and manage the Therapeutics QA activities for the release and distribution of therapeutics products.
May manage team of QA Officers.
Key Responsibilities:
1. Undertake QP responsibilities as defined in Directive 2001/83/EEC and the Code of Practice for Qualified Persons of the Institute of Biology, the Royal Pharmaceutical Society and the Royal Society of Chemistry as appropriate and ensure compliance of the operation witH the requirement of the manufacturing licence.
2. Ensuring that as a professional QP the job holder undertakes CPD as appropriate and ensure that their knowledge of the doseage forms, manufacturing processes and the relevant cGMPs are current and up to date.
3. Ensuring that their personal technical and professional knowledge of all the relevant company processes and quality management systems is sufficient for them to undertake their duties as a QP at Haverhill and in particular with respect to their knowledge of the upstream manufacturing activities on which they must rely in certifying and releasing finished products.
Responsible For:
1. Coordinating (with US QA, QC, Materials Management) the timely release of product for European supply for all therapeutic products
2. Coordinating (with Lyon QA, QC, Materials Management) the timely release of product for world wide supply for all plyclonal products.
3. Ensuring suitable contracts and technical agreements are prepared and implemented
4. Coordinating with Manufacturing Sites and Regulatory Affairs to provide support for licence submissions and reviewing CMC requirement to ensure correct distribution practices.
Responsible for aiding release of clinical supplies with Europe.
Notify senior management of any issues related to GxP, product quality and any other matter that requires their attention.
Provide support to Corporate Compliance in the auditing of facilities, contractors and key suppliers against Marketing Authorisations and European GMPs.
Knowledge/Skills / Experience:
Must be eligible for QP status under the transitional or permanent provisions and have knowledge and experience relevant to the product range and manufacturing processes.
Must have good interpersonal skills
Must be able to manage a small team of professional QA staff
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.
Key Competencies : Attention to Detail / Relationship Building / Communication
To apply please send your updated CV in MS Word format to dericb@adaptresourcing.co.uk
