Cranleigh Scientific: Qualified Person-QP-Permanent-Suffolk-£60k-£70k-Pharmaceutical


Description
My client a leading pharmaceutical company based in Suffolk is recruiting for a Qualified Person (QP). The main purpose of the role to act as a Qualified Person and manage the Therapeutics QA activities for the release and distribution of my clients therapeutics products. Salary bracket for this role is £60,000k - £75,000k plus Strong company benefits

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 and ensure compliance with the requirement of the manufacturing licence.
2. Ensuring that as a professional QP the job holder undertakes CPD as appropriate and ensures that their knowledge of dosage 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 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 the timely release of product for European supply for all therapeutic products.
2) Ensuring suitable contracts and technical agreements are prepared and implemented between my client and contractors , relating for example to the manufacture, packaging, testing and distribution of medicinal products. 3) Coordinating with Manufacturing Sites and Regulatory Affairs to provide support for licence submissions and reviewing CMC requirement to ensure correct distribution practices.
4) Responsible for aiding release of clinical supplies with Europe.
5) Notify senior management of any issues related to GMP, product quality and any other matter that requires their attention.
6)Review and approve SOP's and other relevant GMP documents relating to the manufacture, labelling and assembly operation, storage, distribution and QC testing of medicinal products.
7) To supervise and train junior staff.
8) To undertake projects as required to contribute to the improvement of site systems and processes.

Qualifications

Must be eligible for QP status under the transitional or permanent provisions.
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
Primary Location
: United Kingdom-England-Suffolk

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