Qualified Person

3 days ago

Staffordshire, United Kingdom H2 CONSULTANCY LTD Full time

**Qualified Person**

Are you an experienced Qualified Person?

Do you have previous experience working within biologics?

We are supporting a leading clinical and commercial manufacturing organisation who have been based in **Staffordshire**for nearly 20 years with the recruitment of a **Qualified Person**.

This business is a key player in their market and they have contributed to the successful roll out of the Covid-19 vaccinations, and are proud to have played their part in the successful roll out of the programme.

You will be responsible for ensuring the timely disposition of GMP batches and acting as a GMP Subject Matter Expert (SME) to facilitate the sites compliance.

This business has not only survived but continued to thrive throughout the pandemic and continue to excel in their area of expertise and within their global group structure. Therefore, this is a great time to join this growing business

**Main responsibilities of the role will include**:

- To be named on the Manufacturing Licence with responsibility for ensuring that the respective regulatory requirements for batch release are met.
- To perform QP duties in accordance with Directives 2001/83/EC, 2003/94/EC, 2001/20/EC, and Eudralex Volume 4, part I, II and III including relevant annexes.
- To support internal and external queries relating to QP responsibilities and batch disposition.
- To ensure that continual professional development (CPD) is maintained.
- To use their own quality and compliance knowledge base to mentor other on-site staff to expand on-site compliance knowledge.
- To utilise knowledge of GMP and quality processes to actively identify, suggest, and participate in site continuous improvement activities.
- To provide quality assurance support to initiate, manage and escalate major and critical compliance issues through the site QMS processes, e.g. Deviations and CAPA.
- To deputise for the alternative Site QP during absence to ensure continuity of business.
- To support staff in providing timely responses to Customer queries and communications relating to GMP compliance and batch release.
- To support the alternative Site QP to ensure there is representation in internal meetings where QP input is required

**Experience Required**

Essential
- Degree in Chemistry, Biology or Pharmacy.
- QP eligibility and associated membership of the Royal Society of Chemistry, the Institute of Biology or the Royal Pharmaceutical Society.
- Extensive experience as a QP within a Biopharmaceutical manufacturing environment, covering both IMP and Commercial product release.
- Experience supporting senior Quality and Operations leaders with GMP compliance and batch release decision-making.
- Hands on experience of developing, mentoring, training and enforcing a site Quality culture.

Desirable
- External Lead Auditor status.
- Computerised System Validation knowledge and experience.
- Hands on experience in implementation and evolution of electronic Business Management Systems.

**Essential Details**

**Position**:

- Qualified Person

**Location** - Staffordshire

**Salary** - £85k + excellent benefits

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