Production Quality Systems Manager

We are looking for an enthusiastic and motivated individual to join our dedicated pharmacy production team in the role of Production Quality Systems Manager. You will be the production lead for quality, managing the production quality systems team. You will have an excellent working knowledge of pharmacy aseptic preparation/manufacturing within a hospital setting. Your responsibilities will include monitoring and ensuring concepts of Quality Assurance, GMP, GDP, GCP Quality Control and legislative requirements are observed by all levels of production staff across production and preparation areas.

• Interview date: Monday 9 December 2024
• 37 hours 30 minutes/week

NO AGENCIES PLEASE

Main duties of the job

You will maintain and improve pharmaceutical quality management systems, leading on investigation of incidents, deviations and errors, supporting CAPAs. You will track and monitor Key Performance Indicators, identifying areas requiring action, implement training, systems improvements and policy development as required. You will support capacity plan monitoring, and governance escalation.

You will provide a key role in supporting production in audit and inspection processes, contribution to action plans, completion of actions and monitoring compliance.

You will work closely with Production Manager, Accountable Pharmacist and Operations Manager, QA/QC Department and Senior Team, collectively supporting quality improvement initiatives and strategy.

You will have exemplary organisational and communication skills and an eye for detail and broad IT skills allowing you to prepare and present complex reports. You will have experience of managing multidisciplinary teams, with a working knowledge of pharmaceutical facilities, quality systems, incident investigation, internal and external audit. You will have Masters level qualification or equivalent qualification or equivalent experience in a relevant discipline, with experience of managing organisational change in response to advancing regulatory standards.

Job responsibilities

To ensure concepts of Quality Assurance, GMP, Quality Control and legislative requirements are observed in conducting all activities. To lead, develop and coordinate quality management systems in support of the production and preparation activity taking place on behalf of the Trust, ensuring patient safety and data validity. To ensure all processes contributing to the manufacture or preparation of all products are conducted in accordance with GMP, GDP, GCP and EL guidelines, relevant SOPs and other regulations.

To continually improve the Quality Management System, the focus of which is to develop, perform and manage quality assurance-related activities from policy level through to coordinating appropriate SOP development, ensuring compliance via undertaking a risk-adaptive audit programme. To ensure that audit results are formally and consistently recorded and reported and that corrective/preventive actions have been requested and documented effectively, including confirmation that actions have been undertaken within specified timeframes and appropriate resources allocated.

To train Newcastle Specials and Pharmacy Production staff and others as required (either directly or indirectly) regarding GMP, GDP, GCP, QA and regulatory audits. To work with senior team to focus on areas requiring improvement. To ensure that Regulatory audits are effectively executed and provide support and direction during the hosting of such audits as necessary.

To assist the Assistant Director of Pharmacy Production and Preparation in the implementation of quality, financial and development initiatives. To maximise at all times the utilisation of production staff, time and facilities particularly in relation to completing and contributing to quality management system.

To deliver a comprehensive and responsive production/preparation service to the RVI and Freeman sites. (Includes Licensed Sterile and Non-sterile Manufacturing, Paediatric CIVA, Chemotherapy, Parenteral Nutrition, Homecare Services). To carry out specific checking and product release activities according to post holders level of checking qualifications. With direct accountability to Accountable Pharmacist when undertaking Section 10 final check and product approval.

Please note it is a requirement of The Newcastle upon Tyne Hospitals NHS Foundation Trust that all successful candidates who require a DBS for the post they have been offered pay for their DBS certificate. The method of payment is a salary deduction from your first months pay.

As a flexible working friendly organisation, we want to be sure that you can work in a way that is best for us and for our patients, and for you. Speak to us about how we might be able to accommodate a flexible working arrangement. If it works for the service, we will do our best to make it work for you.

Person Specification
Knowledge
Essential

• Pharmaceutical Audit. MHRA/ Aseptic Dispensing Requirements for the provision of pharmacy production and/or preparation services.
• Extensive practical and theoretical knowledge of Good Manufacturing Practice (Rules & Guidance for Pharmaceutical Manufacturers and Distributors) and Part 10 exemption.
• Working practical and theoretical knowledge of Good Distribution Practice (Rules and Guidance for Pharmaceutical Distributors).
• Working practical and theoretical knowledge of Good Clinical Practice (Good Clinical Practice Guide).
• Validation/documentation/QA/drug administration equipment & methods/aseptic technique, contamination control and environmental monitoring.
• Working knowledge of isolator and/or laminar flow technology.
• Application of health and safety and COSHH in pharmaceutical setting.
• Requirements for training of all grades of technical and professional staff in the production setting.

Desirable

• Experience in the preparation of parenteral nutrition, cytotoxic chemotherapy, intravenous additives, Homecare. Manufacture of nonsterile/sterile medicinal products under 'specials license'.
• Clinical Pharmacy experience.
• Working knowledge of sterilisers for pharmaceutical application/ WFI systems.
• Microbiology/formulation/product design, and the chemical, pharmaceutical and clinical properties of ingredients.

SKILLS
Essential

• Excellent interpersonal and communication skills.
• Organisation and planning skills.
• Leadership and management skills.
• Negotiation, persuasion and problem-solving skills.
• Project management skills and knowledge.
• Research and audit skills.
• Broad IT skills.
• Service improvement/change management skills.
• Well-developed report writing and analytical and presentation skills.
• Effective staff management skills.
• Evidence of relevant continuous professional development.
• Ability to lead meetings.
• Counselling/mentoring.
• Interviewing/appraisal.
• Competency in using pharmacy computer systems.

EXPERIENCE
Essential

• Relevant experience of working in a licensed production unit and/or unlicensed preparation unit.
• Audit of services by external auditing organisation i.e., MHRA and/or Regional Quality Assurance Specialist.
• Managing/training staff.
• Extensive theoretical and practical experience of governance, audit and policy development in a range of settings to Masters level or equivalent.
• Proven experience in a GMP/GDP/GCP environment and/or quality setting, including policy developments.
• Experience of preparing for external inspection.
• Experience of monitoring compliance with national risk management/quality standards.
• Ability to work strategically.

Desirable

• Experience as a senior Pharmacist or senior Pharmacy Technician or production technician.
• Demonstrable staff management.
• Policy design and implementation.
• Trained in appraisal skills.
• Experience in a corporate leadership role.
• Extensive of conducting pharmacovigilance audits.

QUALIFICATIONS
Essential

• Masters level qualification or equivalent qualification or equivalent experience in a relevant discipline.

Desirable

• S/NVQ Level 3 in Pharmacy Services and approved underpinning knowledge e.g. BTEC in Pharmaceutical Science or equivalent recognised pharmacy technician qualification (post graduate level). or production technician.
• Registered with GPhC or Science Council.
• Recognised Accredited Checking Technician qualification.
• Nationally recognised Product Approval Accreditation programme.
• M Pharm (or equivalent) degree course and preregistration.
• Registered Pharmacist (MRPharmS).
• Clinical Diploma.

Employer details
Employer name
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Address
Royal Victoria Infirmary
317 02 Royal Victoria Infirmary
NE1 4LP
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