Technical Validation Specialist

**Overview**:
**Reporting To**: Head of Quality

**Location of Work**: Office based in Greater Manchester - Bright Building, Manchester Science Park, flexible office/hybrid home based arrangements are available.

NorthWest EHealth (NWEH) specialises in delivering clinical trials driven by Electronic Health Record (EHR) data and have close relationships with academia and the NHS.

The world leaders in this field, we have created new market standards for the evaluation of healthcare interventions and work with global pharmaceutical companies.

With a new and modern location in Manchester Science Park, NWEH are currently looking for talented, innovative, and passionate people. This is an excellent opportunity to join an organisation that is at the forefront of pioneering how electronic healthcare data can be utilised to benefit patients while enabling informed decision making to support and empower new models of clinical research.

NWEH delivers a wide range of projects and programmes of work; from large clinical trials to EHR data enabled pragmatic clinical trials as well as feasibility studies utilising routinely collected healthcare data. We work primarily with pharmaceutical and NHS-related clients and are the market-leader in providing these services.

**Job Purpose**:
An opportunity exists for an enthusiastic and organised Technical Validation Specialist with prior experience in GxP/CSV and Information Security to support validation and qualification activities in line with regulatory requirements and industry best practice. You will be part of our creative and collaborative Quality team and will provide technical quality support to operational delivery, new business projects and quality initiatives.

You will be joining an innovative and growing organisation who are driving a revolutionary new approach in clinical trials. Our use of data and advanced software helps to improve the way clinical trials are conducted and maximises patient safety.

**Responsibilities**:

- To provide support to ensure activities conducted by NWEH remain compliant with applicable legislation and regulatory requirements, including ISO/IEC 27001 and 9001
- Make proposals and implement actions as part of quality improvement initiatives in line with the Business Plan and organisational objectives
- Internal auditing of working practices against Standard Operating Procedures, standards, and regulatory requirements
- Responsible for technical writing and reviewing documents such as work instructions, user documentation, and guidance documents
- To ensure that technical quality requirements are communicated and understood within the business
- Participate as required in regulatory inspections, customer and internal audits
- Support to Head of Quality and wider organisation to ensure NWEH is inspection ready
- Support activities to monitor, audit and report on service performance and security in order to identify and address areas of risk and ensure compliance with service level expectations
- Produce Quality reports as required
- Collaborate with key stakeholders, where required, to solve critical technical and delivery challenges
- Support the development and delivery of training materials to wider organisation to support quality and information security initiatives
- Facilitate effective working relationships between the NWEH Quality Team with key stakeholders, both internally and externally (e.g. IG Leads, Auditors, Regulators, Suppliers)
- To keep abreast on new technologies/regulations impacting the business and align with industry expectations and requirements on qualification/validation
- Adhere to NWEH and partner organisation’s policies, processes, provisions, deployment and maintenance standards and procedures
- Support to routine administration tasks as required
- Participate in occasional out-of-hours emergency / urgent work cover as required

**Essential skills**:

- Higher education qualification in a Scientific discipline or related field or equivalent experience (5 Years)
- Experience in quality management roles (3 Years)
- Experience of working in a technical quality management role within the context of software development
- Experience of Qualification/Validation in the pharmaceutical/ life sciences industry
- Experience of using both waterfall and agile methodology
- Exposure to software testing, and awareness of software testing practices and approaches
- Excellent problem-solving skills and the ability to explain complex technical concepts to a wide range of audiences
- Proactive approach and ability to multitask within a fast-paced environment
- High-level of written and verbal communication skills
- Understanding of preparing and maintaining team activities to meet standards set by regulatory bodies
- Internal auditing experience
- Proven track record of making quality improvements in a complex organisation
- Confident communicator and able to work within a team to enable delivery of wider business objectiv