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Expert Gmp Inspector-£71,000-£73,000 P.a. +

1 month ago

South Mimms, United Kingdom Medicines and Healthcare Products Regulatory Agency Full time

**Details**:
**Reference number**:

- 257964**Salary**:

- £73,000**Job grade**:

- SCS Pay Band 1**Contract type**:

- Permanent**Business area**:

- Healthcare Quality & Access**Type of role**:

- Other**Working pattern**:

- Full-time**Number of jobs available**:

- 1Contents

Location

About the job

**Benefits**:
Things you need to know

Location
- Canary Wharf, London/South Mimms, Hertfordshire/Home workingAbout the job

**Job summary**:
We are currently looking for an **Expert GMP Inspector** to join our Standards & Compliance Team within the **Healthcare Quality & Access** group.

This is a **full-time **opportunity, on a **permanent **basis. The role will be based in 10 South Colonnade, Canary Wharf London, E14 4PU/South Mimms, Hertfordshire/Home working. Please be aware that this role can only be worked in the UK and not overseas. We are currently implementing a flexible, hybrid way of working, with a minimum of 4 days per month working on site to enable the collaboration and contact with partners and stakeholders needed to deliver MHRA business. Attendance on site is driven by business needs so depending on the nature of the role, this can flex up to 8 days a month, with the remainder of time worked either remotely or in the office. Some roles will need to be on site more regularly. Remote working is potentially available for some specific roles. Please discuss this with the recruiting manager before accepting an appointment.

**Who are we?**

The Medicines and Healthcare products Regulatory Agency enhance and improve the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research.

The objective of the Healthcare Quality and Access Group is to drive quality and critically appraise benefits and risks to inform robust decisions on healthcare access including accelerated access pathways.

The Standards & Compliance function enables innovation and healthcare access across the global product lifecycle by risk proportionate standards development and compliance through the British Pharmacopoeia and MHRA Laboratory, the Compliance Teams, the Inspection Action Group and Devices Audit and Compliance.

**Job description**:
**What’s the role?**

Expert Inspectors perform a crucial role in developing the agency’s GxP inspection strategies & legislation, providing technical leadership, guidance, and support to the GxP Compliance Teams. They achieve this through engagement with industry, government, and regulatory partners at a national and international level, influencing the global approach to medicines regulation and inspections.

**Key responsibilities**:

- To lead the development of the respective GxP Inspection strategies and inspection models linking Agency and Government priorities to the work of the Group and the wider GxP Compliance Teams, including development and integration of enabling inspections supporting innovation.
- To play a role in the leadership of the Compliance Teams as a member of its senior team, providing sound technical leadership to the respective GxP Compliance Team, and to provide support, mentorship (including management should circumstances require) and guidance to Inspectors in the respective GxP Compliance team.
- To represent the Compliance Teams, Group and Agency at national and international level amongst government, national regulators, and industry groups, for example influencing the approach to medicines regulations and inspection issues, undertaking high profile presentations at conferences, chairing and participating in project groups.
- To lead the respective GxP horizon scanning activities, provide advice on the required future team direction to prepare for emerging developments.

**Person specification**:
**Who are we looking for?**
- Extensive GMP knowledge and experience
- Proven track record in conducting GMP Inspections in a regulatory capacity
- Technical leadership experience
- Effective decision maker
- Excellent communicator and influencer

If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification

**_

**Benefits**:

- Annual Leave: 25 days annual leave on entry, rising by one day for each completed year of service to a maximum of 30 days and pro-rata for part-time staff. PLUS 8 bank holidays
- Privilege Leave: 1 day
- Hours of Work: 37 hours (net) per week for full time staff in all geographical locations, including London and pro rata for part-time staff
- Occupational Sick Pay (OSP): One month full pay/one month half pay on entry, rising by one month for each completed year of service to a maximum of five months full pay/five months half pay
- Mobility: Mobility clause in contracts allowing staff to be mobile across the Civil Service
- Flexible working to ensure staff maintain a healthy work-life balance
- Interest free season ticket loan or bike loan
- Employee Assistance Services and access to the

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