Qualified Person

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

Job Purpose:

As a holder of an MIA(IMP) issued by the MHRA to allow Imanova Ltd (as a subsidiary of Perceptive) to manufacture Investigational Medicinal Products one or more persons able to act as Qualified Persons under Article 49 of Directive 2001/83/EC must be retained to carry out the duties defined in Article 51 of the same directive.

This role exists in order to fulfil these obligations, to permit the certification of Investigational Medicinal Products for human administration and to provide Qualified Person oversight of activities relating to the supply of medicinal products in line with regulator expectations.

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

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