SQCL Lead Technician Quality Management and Validation

If you share our passion then apply for this opportunity and help us make our patients’ experience the best it can possibly be.

With a budget of around £365m, three hospitals and 5,500 staff, North Tees and Hartlepool NHS Foundation Trust provides hospital-based services to the population of Hartlepool, Stockton on Tees and parts of East Durham and Sedgefield as well as community, therapeutic and screening to a wider population across Durham and Teesside.

Job overview

*Advert will close early once sufficient volume of applications is reached*

The purpose of the role is to support the Head of QMS and Validation (Quality Manager) in the development, implementation and management of the Pharmaceutical Quality System in accordance with current Good Manufacturing Practice.

The post holder will work collaboratively with all members of the team including supervising the Quality Technicians and acting as Duty Quality Assessor.

Provide support within the laboratory by participating in the Duty Manager rota, when required.

• In the absence of the Quality Manager, chair the Laboratory Quality Meeting and present reports to Section Heads on quality and operational key performance indicators.
• Deliver specialist training in quality management and good manufacturing practices to laboratory staff and customers whose background may not be quality management.
• In the absence of the Quality Manager, to act as a deputy, in order to provide advice and guidance in relation to the laboratory pharmaceutical quality system.
• When required, act as chair for the laboratory quality meetings and represent the laboratory at MHRA audits of customer facilities.
• To supervise the Quality Technicians including performance of appraisals and one to ones.
• Assist with performance of internal audits of the laboratory service to ensure compliance with the requirements of the pharmaceutical quality system, GMP and relevant standards and to produce reports to outline audit findings.
• Assess the effectiveness of the pharmaceutical quality system and in conjunction with the other members of the Quality Department, implement changes as required.
• To understand and implement quality management principles which will include investigating deviations and developing procedures and controlled documents.

Working for our organisation

At North Tees & Hartlepool NHS Foundation Trust our main priority is, and always will be, to provide safe and high quality care to our patients every day; the kind of care we would want for ourselves and our loved ones. We want our organisation to be the best place to work with the right staff, in the right roles, at the right time, to ensure we deliver exceptional patient care and experience.

We are an Active Hospital and strongly encourage participation of all staff and patients. We expect MECC for all our people interactions.

We will support staff through providing an inclusive and supportive workplace with health and well-being initiatives, staff benefits and opportunities for personal and professional development. Staff recognition is very important to us; as well as performance reviews and appraisals, we recognise staff through Star and Team of the month, colleague recognition – a note of thanks, Managers Awards, Shining Stars and Service Awards.

We recruit for values and “Together we are North Tees & Hartlepool”

• · To report directly to the Head of QMS & Validation (Quality Manager) on issues relating to quality management within the laboratory
• The post holder will be required to communicate with other Quality Control Staff and clients unfamiliar with quality management principles

• To lead, as necessary, and take part in audits of the laboratory by external bodies such as the MHRA and customers. Introduction and validation of updated or new cost effective quality management processes.

Person specification

Qualifications

• • Degree or equivalent level of qualification in a relevant subject

• Qualification relevant to Quality management

Experience

• • Experience within a GMP inspected laboratory, understanding of cGMP and current pharmaceutical quality management
• • Experience of performing root cause analysis
• • Experience supervising staff

• Knowledge of Pharmaceutical Quality Control processes

Experience

• Experience of auditing a laboratory

Skills

• Computer literate

Approach

• • Ability to communicate effectively to a range of people with conflicting priorities
• Ability to train others
• Ability to influence others

**Please note - Once sufficient applications have been received this vacancy may close early**

Please check your email address on a regular basis as applicants invited to attend an interview will be notified via this method.

As part of our recruitment process, you will be required to undertake pre-employment screening: Disclosure and Barring Scheme (previously Criminal Records Bureau)

Where a post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 it may be necessary for a submission for Disclosure to be made to the Disclosure and Barring Scheme to check for any previous criminal convictions. Should you require a copy of the Trust's Disclosure and Barring Service Policy, please contact a member of the recruitment team on 01642 624023.

The method of payment for this is via salary deduction from your first month's pay on commencement with the Trust.

Please note the essential qualifications required for the post outlined within the Person Specification. You are required to hold and provide evidence of the necessary qualifications for the post at interview should you be shortlisted.

For any new employees commencing employment with North Tees and Hartlepool NHS Foundation Trust , you will be subject to satisfactory completion of a 6 month probationary period. Please note that internal applications and individuals that are appointed to fixed term appointments of less than 6 months duration are exempt from the probationary period (unless you are an internal applicant currently part way through a probationary period or a bank member of staff).

Personal references are not acceptable.

If the hours advertised for the post are up to full time (37.5 hours per week), applications are still welcomed from individuals who may be seeking to work less than full-time hours and all requests will be considered in line with the post being appointed to for the successful applicant.

North Tees & Hartlepool NHS Foundation Trust operates a No Smoking Policy.

If you experience any technical difficulties applying for this post please contact a member of our recruitment team on 01642 624023 quoting the vacancy reference.

Equal Opportunities

As such we welcome your application irrespective of your gender, race, disability, colour, ethnic or national origin, and nationality, and marital status, responsibility for dependants, religion, trade union activity and age.

Disability

If you have a disability, which makes it difficult for you to complete our application form, please do not hesitate to contact the recruitment team on 01642 624023.

Armed Forces Covenant

As a supporter of the Armed Forces and an employer of Reservists, North Tees and Hartlepool NHS Foundation Trust are proud to be a signatory of the Armed Forces Covenant, which is a promise by the nation to ensure that those who serve or who have served in the UK Armed Forces (and their families) are treated fairly.

We recognise that reservists and veterans bring a variety of transferable skills and qualities to our workplace, developed through their military careers. Our commitment to supporting the Armed Forces Community has been recognised through the Armed Forces Covenant as a Silver Employer.

What does this mean?

We have supported employees through Reservist training, through additional leave for their training and ongoing support under our Special Leave policy.