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.
- Fulfilling the requirements of Annex 16 of the Rules and Guidance for Pharmaceutical Manufacturers and Distributors as they apply to Imanova Ltd
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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
- Demonstratable ability to apply critical thinking to problems and tasks
- 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