Technical Validation

Salary: £54,000 – £62,400 per year

Technical Validation Specialist /. Technical Quality Engineer / Quality Engineer

(Electronic Health Records used to advance Clinical Trials and Drug Development)

Home based role with access to prestigious offices in the Manchester area circa 1-2 times per month

Base Salary £54,000 – £62,400

Solution — The “data” held within Electronic Health records is analysed and interpreted by software and that is subsequently used as a service that advances drug development. The data is used to direct research and deliver tangible benefits to research-based companies – BIG PHARMA developing new pharmaceutical products / drugs. The solutions afford clinical customers a real time “live” searchable database that provides a wealth of information to assist companies’ developing pioneering lifesaving drugs and devices cutting development time, saving money, and impacting the health of millions globally. Their technology connects electronic health records (EHRs) across primary and secondary care, and enables rapid patient recruitment, reduces clinical trial development time and costs. It also increases responsiveness to patient safety through near real-time monitoring. This technology could be applied to any established health economy across the globe. This has the potential to change the way that clinical trials are conducted in the future by ensuring drugs get to market faster and therefore improving patient outcomes.

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:

• Support and lead activities to ensure validated status of our developed applications is maintained in line with GxP requirements.
• To provide support to ensure activities conducted 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.
• To act as a technical quality subject matter expert during investigation of non-conformances and breaches through to appropriate CAPA closure.
• 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 we are 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 internal 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 internal 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 a clinical research or life sciences setting.

Experience of Qualification/Validation in the pharmaceutical/ life sciences industry.

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 objectives.

Understanding and experience of identifying and resolving IS risks in a technical environment.

Excellent gap analysis skills.

Proven track record of working effectively with project teams to establish and deliver quality excellence.

Good attention to detail and ability to see tasks through to successful completion.

Desirable skills: 

Proven track record of maintaining Quality and Information Management systems in line with ISO 9001 and ISO/IEC 27001 certification and relevant experience in writing related documentation.

Experience of working with confidential/sensitive data.

Knowledge and understanding of ICH/GCP requirements.

Line management experience.

Internal Auditor qualification.

Experience of working with JIRA/Q-Pulse.

Benefits: 

• Competitive Salary
• 27 day’s annual leave
• Flexible working hours
• The ability to work from home
• Modern offices in Central Manchester
• Positive and supportive environment
• Access to training resources