Qp Application

**JOB PURPOSE**

To perform duties in accordance with "Qualified Persons Code Of Practice In The Pharmaceutical Industries" and current EU/UK legislation. This will include certification of finished marketed products prior to release for sale, and bulk clinical and clinical packaged & labelled product batches for release. In addition, to provide Quality & Compliance leadership to Site Operations to ensure that all site and global Quality processes operate to the highest standards of compliance.

**KEY RESULTS/ACCOUNTABILITIES**

Named on the Site’s Marketed Product and IMP (Investigational Medicinal Product) Manufacturing Licenses with responsibility to perform certification of finished marketed products in line with current legislation (Article 49 of Directive 2001/83/EC) and registered details, and bulk clinical drug product and clinical packaged & labelled product batches for release in accordance with Article 13.3 of Directive 2001/20/EC, using the Product Specification File as the basis of assessment for suitability.

To ensure regulatory and internal standards are met and maintained, procedures and systems are followed and the requirements of batch release are achieved in a compliant and timely manner.

Responsible for reviewing and approving batch related documentation in accordance with the purpose for which the batch is intended.

To develop, review and approve Standard Operating Procedures, Validation documentation, Failure investigations, Change Control documentation, Specifications, Batch Manufacturing documentation, Certificates Of Analysis, Complaints reports and any other required cGMP documentation.

To monitor and improve Site Quality systems, ensuring that they continue to meet the Site and Regulatory requirements.

To participate in Quality Improvement Programmes within Site Operations acting as the QA functional representative, providing support and input into relevant projects and investigations ensuring the compliant development of Site Operations.

To provide cGMP guidance and coaching for Site associates to maximise achievement of the right first time KPI.

Implement a programme of Continuous Improvement based on data / trending from all available sources within Site Operations.

To plan and conduct Self Inspection and External Vendor audits of suppliers and contractors, producing written reports in a timely manner. Ensuring that cGMP's are implemented and followed, by use of a defined and approved corrective action plan and system of monitoring.

To provide co-ordination and planning support within Quality Operations, including support to ongoing audit preparedness and hosting of external inspections.

To establish and maintain an effective communication network and working relationship with peer Quality professionals within other Recipharm sites.

***KEY WORKING RELATIONSHIPS
*

**INTERNAL**
**Regular, close contact with: QC Team Leaders and Managers, Shift Team Leaders and Operations Managers, Engineers, Validation, Regulatory**
**Occasional contact with**

**EXTERNAL**
**Regular, close contact with: Customers**
**Occasional contact with**: Corporate Quality Contacts

**SKILLS, EXPERIENCE & KNOWLEDGE REQUIREMENTS**

QP Status.

Competence Profile:
Up-to-date knowledge of current EU and USA Good Manufacturing Practice and guidance as related to the Pharmaceutical Industry is essential.
Experience of participation in MHRA and FDA cGMP audits is necessary.
The required level of experience will have been acquired over a period of not less than 5 years and preferably have covered a number of different pharmaceutical dosage forms.

**RECIPHARM CORE VALUES**

Tenacity, Reliability, Professionalism, Entrepreneurship