Band 8b Quality Assurance Specialist

Job responsibilities

1. RESPONSIBILITY FOR POLICY AND SERVICE DEVELOPMENT

To deliver the key targets for the Trust research and development agenda as agreed between the post holder and the Head of Pharmaceutical Quality

To ensure the pharmaceutical quality management system is maintained and developed in accordance with the ML (specials) and MA (IMP) license requirements and in response to changes in regulations and legislation.

To ensure Trust GMP Internal Audit Programme and audits are reported and actioned in a timely manner.

To ensure QA requirement for validation master plan are fully completed and documented

To assist in the review of service contracts and technical agreements with suppliers.

To assist in the review and update of QA/QC procedures.

To assist in the review and update of specifications for raw materials, finished products, packaging materials and labels.

To assist in the review, update and approval of manufacturing documents and procedures.

To establish and implement procedures for environmental monitoring in the Pharmacy Production and preparation areas and to maintain records of the monitoring completed.

To act as a Quality Controller for piped medical gases adhering to the requirements of HTM02 and assist in providing medical Gas Testing service across the sites

To assist in the qualification, commissioning and validation of new facilities and equipment.

To assist in the approval of standard operation procedures within the Pharmacy Production and QA/QC units.

To contribute to the formulation of patient specific medicines in response to the individuals clinical needs.

To undertake GMP audits of external suppliers as required.

To assist in maintaining the Quality Management System used by all Trust licenced facilities. This involves effective management of non-compliance reviews, implementation and management of agreed action plans, advice and technical input into investigations and quality risk management issues.

To assist in the effective management of the Change Control and Unusual Events programme ensuring improvements and any regulatory changes are assessed and implemented.

To assist in the development and management of a robust document control system as an integrated part of the Quality system according to GCP and MHRA requirements.

To establish and implement procedures for the department wide temperature monitoring system in the medicine storage areas which includes but not limited to pharmacy production and preparation areas, dispensary areas, stores and clinical trial areas and review record of alarms generated.

To respond to customer complaint and investigate and report on defective medicines for Trust manufactured products.

To coordinate the trust response to Drug Alerts issued by the MHRA.

2. Staff Supervision and Training

• To train and supervise the work of the laboratory technical staff to undertake method development and ensure that activities undertaken meet current legislative guidelines such as GMP/GDP. GCP, Health and safety, COSSH.
• To assist in managing staff assigned to the QA/QC Department including objective setting, performance and attendance monitoring
• To participate in the training of pharmacists, chemists, pre-registration pharmacy graduates, technicians and student technicians with the QA department and external to the trust as necessary.
• To complete appraisals for junior QA/QC staff as requested by the Head of Pharmaceutical Quality.
• To manage staff under the Trust Sickness and Rehabilitation process as requested by the Head of Pharmaceutical Quality.

3. Resource Management

• To assist in the planning for equipment procurement and ensure that equipment and plant is adequately qualified and maintained and its performance continuously verified.

4. Research and Development (including Clinical Trials)

• To provide support to the development, formulation and validation of new products in response to clinical trial and clinical need and risk management in accordance with client and trust objectives.

To develop robust stability indicating analytical methods to support formulation studies.

• To undertake, supervise and give guidance on the preparation of pharmaceutical clinical trial materials used within the Trust.

To review all new trial documentation and assess whether the production of the Investigational medicinal product (IMP) comes under the MA (IMP) license

Education & professional Qualifications

Essential

• Pharmacist or relevant Science degree
• Full membership of a relevant Professional Body
• Mandatory CPD to maintain fitness to practice

Desirable

• Further qualification in relevant technical or management area
• European Computer Driving Licence

Royal Free World Class Values

Essential

• Demonstrable ability to meet the Trust Values

Experience

Essential

• Proven experience of good performance in previous jobs
• Extensive experience in pharmaceutical manufacturing, including experience in a large licensed facility
• Experience in a QC Laboratory linked to a MHRA Licensed Pharmacy Manufacturing Unit and a QA Department with analytical experience using UV, IRand HPLC methods
• Previous experience in validation of pharmaceutical manufacturing processes
• Experience of managing & motivating staff
• Experience of training and supervising staff
• Demonstrated experience & ability to successfully supervise and undertake a range of technical projects
• Demonstrated expert technical knowledge covering Pharmaceutical QA and Production
• Knowledge of all aspects of cGMP, and all current legislation and regulations and ability to apply this knowledge to develop and run Quality Services
• Demonstrated knowledge of principals and practices of aseptics/parenterals e.g. formulation, stability, administration, legal issues
• Knowledge of COSHH and health and safety at work
• An awareness of current national standards, guidelines and service delivery issues relevant to Technical Services and ability to apply these to Quality Services
• Demonstrated knowledge of cGMP/GLP/ Quality Systems
• Demonstrated knowledge of Validation requirements of pharmaceutical facilities and Audit
• Demonstrated knowledge of Pharmaceutical microbiology
• Demonstrated knowledge of Medical Piped Gas Testing

Desirable

• Previous experience in the development and validation of analytical methods
• Previous experience in the design, development and undertaking of stability studies

Skills and aptitudes

Essential

• Demonstrated ability to identify problems, analyse root cause and propose solutions for complex problems
• Demonstrated expert technical knowledge of GLP and GMP, and a proven ability to apply this knowledge to maintain, develop and validate quality systems
• Demonstrated Project Management Skills
• Demonstrated ability to manage routine out of specification results and incidents and develop and review action plans to resolve these
• Able to communicate effectively with all healthcare professionals and colleagues
• Able to identify and manage risks
• Able to solve difficult and ambiguous problems by advanced reasoning and sound technical judgement
• Able to deliver and validate staff training
• Able to manage and support others undertaking research
• Able to manage non compliances and incidents and develop and review action plans to resolve them
• Able to write business cases
• Able to develop and review options appraisal's and identify the most appropriate option
• Effective leadership skills
• Able to prepare and complete documentation accurately with attention to detail, even when under pressure
• Able to work effectively in stressful situations
• Demonstrated ability to perform accurate complex calculations & numeracy skills and to teach these
• Able to plan, prioritise and organise self
• Able to plan, prioritise and organise the work of others
• Able to meet deadlines
• Able to work unsupervised
• Advanced IT skills including email, word processing, spreadsheets, databases, accurate data entry and use of specialist computer programmes
• Demonstrated effective customer service skills
• Good team worker
• Demonstrated ability to deliver lectures, workshops and formal presentations
• Critical Appraisal skills
• Able to follow local Manual Handling procedures
• Able to manage change
• Demonstrated evidence of the safe handling of hazardous materials
• Demonstrated ability to manage and deliver a Research and Development Agenda

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).

UK Registration

Applicants must have current UK professional registration. For further information please see NHS Careers website (opens in a new window).