Qualified Person

1 week ago


London, United Kingdom Perceptive Full time

**_What can we offer you? _**
- Apart from job satisfaction, we can offer you: _

**_YOURSELF _**
- _25 days’ holiday (with the option to buy more) _

**_HEALTH _**
- _Private Healthcare _
- _Optional dental insurance, health assessments and health cash plans _
- _Cycle to Work scheme _

**_WEALTH _**
- _Company Pension Scheme, matching contributions up to 5% of salary _
- _Life assurance _
- _Annual staff bonus scheme _
- _Season ticket loans _

**Key Accountabilities**:
**QP Release and Certification of IMPs**
- Acting as a Qualified Person for Perceptive Discovery by inclusion on the MIA(IMP) for Imanova Ltd.

**Non-IMP Release**
- Acting as a Releasing Person for the release of non-IMPs for clinical use

**Quality System Oversight**
- Undertaking of internal and third party audits as required.
- Periodic Review of
- Regulatory Status
- Status of Procedures and Systems
- Applicable Change Controls
- Relevant Batch Data
- Complaints and Adverse Events
- Deviations
- Status of Manufacturing Authorisations (Regulatory and Company)
- Precursor Certification/Supply Chain
- TSE Compliance
- Data Integrity

**Other**
- Carryout any other reasonable duties as requested.

**Skills**:

- Excellent interpersonal, verbal and written communication skills
- A flexible attitude with respect to work assignments and new learning
- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
- Must have the ability to work methodically in a fast-paced, time-sensitive environment
- Ability to identify and implement process improvements
- Proactively participates in skills improvement training and encourages their teams to participate
- A self-starter and able to work under own initiative
- Ability to work across functional and inter-organisational interfaces.

**Knowledge and Experience**:

- Current eligibility to be nominated as a Qualified Person
- Significant relevant experience, gained within QA roles within the pharmaceutical industry
- Experience of QP activities related to radiopharmaceuticals, investigational medicinal products and small volume aseptic operations

**Education**:

- Bachelor's Degree in a technical discipline (Maths, Science, Engineering, Computing, etc.) or a related study, or equivalent project-related experience
- English: Fluent


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